Safety, Tolerability and Pharmacokinetics of Cobimetinib... | NCT00996892 | Trialant
NCT00996892
Sponsor
Genentech, Inc.
Status
Terminated
Last Update Posted
Dec 30, 2016Estimated
Enrollment
178Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
Cobimetinib
Pictilisib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00996892
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MEK4752g
Secondary IDs
ID
Type
Description
Link
GO01330
Other Identifier
Hoffmann-La Roche
Brief Title
Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors
Official Title
A Phase Ib, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2016
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
A recommended Phase 2 dose and schedule was not identified and the study was terminated before initiation of Stage 2B.
Expanded Access Info
No
Start Date
Nov 2009
Primary Completion Date
Mar 2014Actual
Completion Date
Mar 2014Actual
First Submitted Date
Oct 12, 2009
First Submission Date that Met QC Criteria
Oct 15, 2009
First Posted Date
Oct 16, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 3, 2016
Results First Submitted that Met QC Criteria
Nov 4, 2016
Results First Posted Date
Dec 30, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 4, 2016
Last Update Posted Date
Dec 30, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
GDC0941
GDC0973
MEK
MEK Inhibitor
PI3K
PI3K Inhibitor
PI3 Kinase
PI3 Kinase Inhibitor
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
178Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation Stage 1: Cobimetinib + Pictilisib
Experimental
Participants will receive cobimetinib capsules (at a starting dose of 20 milligrams [mg]) and pictilisib capsules (at a starting dose of 80 mg) from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Doses will be increased to identify maximum tolerated dose (MTD) or potential recommended Phase 2 dose (RP2D). Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets.
Participants will receive cobimetinib capsules (at a starting dose of 100 mg) on Days 1, 4, 8, 11, 15, and 18 and pictilisib capsules (at a starting dose of 130 mg) from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Doses will be increased to identify MTD or potential RP2D.Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets.
Participants will receive cobimetinib capsules (at a starting dose of 40 mg) and pictilisib capsules (at a starting dose of 130 mg) from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants will be off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets.
Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B
DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.
Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28
Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B
MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.
Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28
Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3
Secondary Outcomes
Measure
Description
Time Frame
Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
Life expectancy greater than or equal to (>=) 12 weeks
Adequate hematologic and end organ function
Agreement to use an effective form of contraception for the duration of the study
Exclusion Criteria:
History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment
History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) pathway inhibitor requiring discontinuation of treatment
Allergy or hypersensitivity to components of the cobimetinib or pictilisib formulations
Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
Prior anti-cancer therapy within 28 days before the first dose of study drug treatment in Cycle 1
History of diabetes requiring daily medication, or history of Grade >= 3 fasting hyperglycemia
Current severe, uncontrolled systemic disease
History of clinically significant cardiac or pulmonary dysfunction
History of malabsorption or other condition that would interfere with enteral absorption
Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
Active autoimmune disease
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Pregnancy, lactation, or breastfeeding
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Iris Chan, M.D., Ph.D.
Genentech, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Baltimore
Maryland
21231
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Study was terminated before initiation of Stage 2B; hence Stage 2B cohorts were not applicable.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Periods
Title
Milestones
Reasons Not Completed
Dose-Escalation Stage 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants will received cobimetinib capsules and pictilisib capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non-small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
Drug: Cobimetinib
Drug: Pictilisib
Dose Expansion Stage 2A: Cobimetinib + Pictilisib
Experimental
Participants received cobimetinib capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1A. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
Drug: Cobimetinib
Drug: Pictilisib
Dose Expansion Stage 2B: Cobimetinib + Pictilisib
Experimental
Participants will receive cobimetinib capsules and pictilisib capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1B. Participants will be off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with KRAS mutant endometrioid carcinoma.
0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4
Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3
0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4
Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3
0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4
Tmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3
0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3
Cmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3
0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3
AUC0-24 of Pictilisib on Day 1 - Stage 1, Cohorts 1-3
0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half.
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22
Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
t1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2
Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19
t1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2
Tmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Cmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19
t1/2 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
CL/F of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
Tmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
Cmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
CL/F of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14
Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2 All Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2
Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
t1/2 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14
Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2
Tmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Cmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
t1/2 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
CL/F of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2
Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
t1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2
Tmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Cmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
t1/2 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
CL/F of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B
Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
Boston
Massachusetts
02114
United States
Boston
Massachusetts
02215
United States
Detroit
Michigan
48201
United States
Oklahoma City
Oklahoma
73104
United States
Nashville
Tennessee
37203
United States
FG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG007
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG008
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG009
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG010
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG011
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG012
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG013
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG014
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG015
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG016
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
FG017
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non-small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
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FG0030 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Expansion Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG01835 subjects
FG0190 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Expansion Stage 2A
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG01945 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Participants
All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Denominators
Units
Counts
Participants
BG000178
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00056.6± 12.0
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000109
Male
BG00069
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B
DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.
Safety-evaluable population included all participants who received at least one dose of study drug. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Number
participants
Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B
MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.
Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants evaluable for specified categories.
Posted
Number
mg
Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28
ID
Title
Description
OG000
All Participants - Stages 1, 1A, 1B
All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Primary
Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3
Pharmacokinetic (PK) population included all participants who had at least one cobimetinib and pictilisib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Primary
Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Primary
Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
nonograms*hour per milliliter (ng*h/mL)
0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Primary
Tmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Primary
Cmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Primary
AUC0-24 of Pictilisib on Day 1 - Stage 1, Cohorts 1-3
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour (L/hr)
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
Secondary
Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
t1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Secondary
CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
Secondary
Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
t1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Secondary
CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Secondary
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
t1/2 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
CL/F of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19
ID
Title
Description
OG000
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Secondary
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Secondary
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
CL/F of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts
Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
ID
Title
Description
OG000
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Secondary
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
t1/2 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
t1/2 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
Secondary
CL/F of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts
Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
Secondary
Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
t1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
Secondary
Tmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Median
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Cmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
t1/2 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Full Range
hours
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
CL/F of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts
Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21
Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.
Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Posted
Number
participants
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Secondary
Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B
Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.
Data for this outcome measure was not collected as per changes in planned analysis.
Posted
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.
Data for this outcome measure was not collected as per changes in planned analysis.
Posted
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
ID
Title
Description
OG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Time Frame
Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)
Description
Safety evaluable population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
2
4
4
4
EG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
0
3
3
3
EG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
25
43
42
43
EG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
6
11
11
11
EG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
6
10
10
10
EG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
2
4
4
4
EG007
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
2
3
3
3
EG008
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
2
3
3
3
EG009
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
28
52
52
52
EG011
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
4
9
9
9
EG012
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
5
8
8
8
EG013
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
3
5
5
5
EG014
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
0
4
4
4
EG015
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
0
3
3
3
EG016
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
0
3
3
3
EG017
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
2
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected43 at risk
EG004
Atrial fibrillation
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colititis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Device occlusion
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ercherichia sepsis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Carbon monoxide diffusing capacity decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung adenocarcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonitits
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0035 affected43 at risk
EG0040 affected11 at risk
EG0053 affected10 at risk
EG0060 affected4 at risk
EG0072 affected3 at risk
EG0081 affected3 at risk
EG0090 affected4 at risk
EG0107 affected52 at risk
EG0111 affected9 at risk
EG0121 affected8 at risk
EG0130 affected5 at risk
EG0142 affected4 at risk
EG0150 affected3 at risk
EG0160 affected3 at risk
EG0170 affected5 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenopia
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinal tear
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vision Blurred
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected4 at risk
EG0013 affected3 at risk
EG0023 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip oedema
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected4 at risk
EG0012 affected3 at risk
EG0023 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral mucosal erythema
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected4 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Catheter site pruritus
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Catheter site rash
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Early satiety
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected4 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Local swelling
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Localized oedema
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cellulitits
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Liver abscess
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Penile infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Viral infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arterial injury
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Incision site rash
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood calcium decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood chloride decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood chloride increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase mb increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood iron decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Carbon dioxide decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haermatocrit decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Heart rate increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Depressed level of consiousness
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Trigeminal palsy
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Stress
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Penile haemorrhage
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pharyngeal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin maceration
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound drainage
Surgical and medical procedures
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pallor
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
The study was terminated prior to the initiation of Stage 2B and as per changes in planned analysis the data for duration of objective response and PFS were not analyzed.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffman-La Roche
800-821-8590
genentech@druginfo.com
ID
Term
D009477
Hereditary Sensory and Autonomic Neuropathies
Ancestor Terms
ID
Term
D009421
Nervous System Malformations
D009422
Nervous System Diseases
D020271
Heredodegenerative Disorders, Nervous System
D019636
Neurodegenerative Diseases
D011115
Polyneuropathies
D010523
Peripheral Nervous System Diseases
D009468
Neuromuscular Diseases
D000013
Congenital Abnormalities
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG007
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG008
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG009
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG010
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG011
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG012
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG013
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG014
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG015
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG016
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG017
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
9
OG00411
OG00510
OG0064
OG0073
OG0083
OG0094
OG0107
OG0119
OG0128
OG0135
OG0144
OG0153
OG0163
OG0175
1
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
OG0132
OG0140
OG0150
OG0160
OG0171
Units
Counts
Participants
OG00098
Title
Denominators
Categories
Stage 1: Cobimetinib (n = 44)
Title
Measurements
OG00040
Stage 1: Pictilisib (n = 44)
Title
Measurements
OG000100
Stage 1A: Cobimetinib (n = 34)
Title
Measurements
OG000125
Stage 1A: Pictilisib (n = 34)
Title
Measurements
OG000180
Stage 1B: Cobimetinib (n = 20)
Title
Measurements
OG000NAMTD for Stage 1B was not determined as the study was terminated prior to initiation of Stage 2B.
Stage 1B: Pictilisib (n = 20)
Title
Measurements
OG000NAMTD for Stage 1B was not determined as the study was terminated prior to initiation of Stage 2B.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG0004.00(2.0 to 4.0)
OG0014.00(4.0 to 4.0)
OG0022.00(2.0 to 2.0)
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00027.6± 95
OG00116.6± 78
OG00297.0± 63
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG000392± 88
OG001279± 75
OG0021190± 53
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG0003.00(2.0 to 24.0)
OG0014.00(2.0 to 4.0)
OG0022.00(2.0 to 2.0)
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG000162± 37
OG001185± 27
OG002280± 41
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG0001680± 16
OG0011950± 50
OG0022680± 83
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0038
OG00411
OG00510
OG0064
Title
Denominators
Categories
Title
Measurements
OG0004.00(2.0 to 4.0)
OG0014.00(2.0 to 24)
OG0022.00(2.0 to 2.0)
OG0032.00(2.0 to 4.0)
OG0042.00(2.0 to 2.0)
OG0054.00(2.0 to 4.0)
OG0063.00(2.0 to 4.0)
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0038
OG00411
OG00510
OG0064
Title
Denominators
Categories
Title
Measurements
OG00020.2± 100
OG00117.7± 62
OG00287.4± 73
OG003101± 63
OG00461.0± 45
OG005131± 66
OG006138± 61
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0038
OG00411
OG00510
OG0064
Title
Denominators
Categories
Title
Measurements
OG000299± 62
OG001311± 53
OG0021320± 56.6
OG0031300± 61
OG004957± 42
OG0052050± 71
OG0061790± 56
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0006.00(2.0 to 6.0)
OG0014.00(4.0 to 6.0)
OG0022.00(2.0 to 24)
OG0032.00(2.0 to 4.0)
OG0044.00(2.0 to 24)
OG0053.0(2.0 to 24)
OG0064(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG00037.1± 5.6
OG00152.2± 57
OG002228± 120
OG003167± 56
OG004138± 63
OG005245± 79
OG00687.4± NAMeasure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG000749± 1.4
OG001900± 70
OG0024130± 94
OG0032410± 66
OG0042460± 57
OG0054050± 110
OG0061120± NAMeasure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG00049.3(41 to 60)
OG00137.9(32 to 43)
OG00231.7(22 to 48)
OG00334.1(32 to 37)
OG00443.2(34 to 56)
OG00545.7(41 to 56)
OG00640.5(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG00026.7± 1.4
OG00122.2± 70
OG0029.67± 94
OG00316.6± 66
OG00416.2± 61
OG00514.8± 110
OG00653.6± NAMeasure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0002.51± 63
OG0012.89± 43
OG0023.14± 73
OG0032.03± 36
OG0042.90± 73
OG0052.83± 54
OG0061.77± NAMeasure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0038
OG00411
OG00510
OG0064
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 4.0)
OG0012.00(2.0 to 4.0)
OG0022.00(2.0 to 2.0)
OG0032.00(0.5 to 4.0)
OG0042.00(2.0 to 4.0)
OG0052.00(0.5 to 4.0)
OG0062.00(2.0 to 4.0)
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0038
OG00411
OG00510
OG0064
Title
Denominators
Categories
Title
Measurements
OG000196± 20
OG001193± 16
OG002329± 26
OG003390± 60
OG004302± 34
OG005272± 54
OG006355± 83
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0038
OG00411
OG00510
OG0064
Title
Denominators
Categories
Title
Measurements
OG0001660± 28
OG0012150± 43
OG0022600± 28
OG0033360± 43
OG0042770± 43
OG0052870± 48
OG0063240± 68
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0048
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 6.0)
OG0012.00(2.0 to 2.0)
OG0022.00(2.0 to 4.0)
OG0032.00(0.5 to 4.0)
OG0042.00(2.0 to 6.0)
OG0052.00(2.0 to 24)
OG0062.00(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0048
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG000198± 38
OG001278± 100
OG002459± 20
OG003409± 49
OG004374± 69
OG005396± 48
OG006441± NAMeasure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0048
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0002500± 21
OG0012930± 150
OG0025500± 34
OG0033890± 63
OG0044320± 58
OG0054510± 40
OG0064070± NAMeasure dispersion not applicable as only one participant was evaluable.
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0032
OG0048
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG00025.8(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG003NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG00424.7(22 to 30)
OG00527.7(22 to 41)
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0048
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG00032.0± 21
OG00134.1± 150
OG00214.5± 34
OG00325.7± 63
OG00430.1± 58
OG00522.2± 40
OG00624.6± NAMeasure dispersion not applicable as only one participant was evaluable.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0048
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0001.51± 47
OG0011.36± 79
OG0022.11± 6.0
OG0031.16± 34
OG0041.71± 29
OG0051.70± 25
OG0062.8± NAMeasure dispersion not applicable as only one participant was evaluable.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0037
OG0049
OG0058
OG0065
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 4.0)
OG0014.00(2.0 to 6.0)
OG0022.00(1.0 to 2.0)
OG0034.00(2.0 to 24)
OG0044.00(2.0 to 6.0)
OG0055.00(2.0 to 24)
OG0064.00(2.0 to 6.0)
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0037
OG0049
OG0058
OG0065
Title
Denominators
Categories
Title
Measurements
OG000301± 87
OG001137± 66
OG002436± 67
OG003184± 47
OG004275± 72
OG005333± 45
OG006311± 48
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0037
OG0049
OG0058
OG0065
Title
Denominators
Categories
Title
Measurements
OG0004950± 80
OG0012320± 61
OG0025520± 59
OG0032620± 50
OG0044250± 75
OG0055100± 47
OG0065090± 45
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 4.0)
OG0012.00(2.0 to 2.0)
OG0022.00(2.0 to 6.0)
OG0034.00(2.0 to 6.0)
OG0044.00(2.0 to 6.0)
OG0055.00(2.0 to 24)
OG0063.00(2.0 to 4.0)
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG000802± 24
OG001372± 45
OG002616± 39
OG003204± 57
OG004409± 43
OG005475± 86
OG006682± 23
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG00013400± 18
OG0015680± 55
OG0029990± 28
OG0033060± 50
OG0046980± 55
OG0057740± 69
OG00611100± 23
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG0036
OG0046
OG0052
OG0064
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG00146.1(32 to 67)
OG00247.4(34 to 63)
OG00348.8(37 to 63)
OG00448(36 to 72)
OG005NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG00646.2(33 to 55)
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG0007.49± 18
OG00117.6± 55
OG00212.5± 28
OG00340.9± 50
OG00417.9± 55
OG00519.4± 69
OG00613.6± 23
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG0002.70± 57
OG0012.44± 60
OG0021.46± 30
OG0031.11± 67
OG0041.52± 120
OG0051.75± 40
OG0061.84± 8.1
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0037
OG0049
OG0058
OG0065
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 4.0)
OG0012.00(2.0 to 2.0)
OG0022.00(2.0 to 2.0)
OG0032.00(2.0 to 24)
OG0042.00(2.0 to 4.0)
OG0052.00(0.5 to 6.0)
OG0064.00(0.5 to 6.0)
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0037
OG0049
OG0058
OG0065
Title
Denominators
Categories
Title
Measurements
OG000547± 80
OG001408± 190
OG002390± 76
OG003367± 61
OG004832± 35
OG005619± 110
OG006514± 81
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0037
OG0049
OG0058
OG0065
Title
Denominators
Categories
Title
Measurements
OG0006900± 62
OG0014900± 170
OG0023670± 72
OG0034280± 48
OG0048440± 32
OG0055650± 88
OG0066680± 53
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 4.0)
OG0012.00(2.0 to 2.0)
OG0022.00(0.5 to 2.0)
OG0032.00(2.0 to 2.0)
OG0043.00(2.0 to 6.0)
OG0052.00(0.5 to 6.0)
OG0063.00(2.0 to 24)
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG000809± 41
OG001709± 71
OG002597± 38
OG003579± 100
OG004833± 49
OG005743± 53
OG006646± 24
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG00011300± 21
OG0017680± 88
OG0026990± 38
OG0036120± 110
OG00412100± 58
OG0058140± 58
OG00610100± 44
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0031
OG0046
OG0052
OG0062
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG001NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG00234.9(29 to 44)
OG00336.5(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG00438.4(27 to 52)
OG005NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG006NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
OG002
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG00011.5± 21
OG00123.5± 88
OG00218.6± 38
OG00329.4± 110
OG00420.3± 58
OG00522.1± 58
OG00624.2± 44
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG004
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0046
OG0056
OG0064
Title
Denominators
Categories
Title
Measurements
OG0001.64± 40
OG0011.57± 45
OG0021.89± 110
OG0031.15± 55
OG0041.56± 42
OG0051.60± 100
OG0061.46± 100
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0035
Title
Denominators
Categories
Title
Measurements
OG0003.00(2.0 to 6.0)
OG0012.00(2.0 to 4.0)
OG0024.00(2.0 to 24)
OG0034.00(0 to 6.0)
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0035
Title
Denominators
Categories
Title
Measurements
OG00055± 160
OG001123± 56
OG00245.6± 110
OG00377.8± 110
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0031
Title
Denominators
Categories
Title
Measurements
OG000855± 150
OG0011750± 77
OG002699± 72
OG0032460± NAMeasure dispersion not applicable as only one participant was evaluable.
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
Title
Denominators
Categories
Title
Measurements
OG0005.00(2.0 to 6.0)
OG0014.00(2.0 to 6.0)
OG0022.00(0 to 6.0)
OG0036.00(2.0 to 6.0)
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
Title
Denominators
Categories
Title
Measurements
OG000174± 50
OG001232± 120
OG002158± 73
OG003245± 45
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0034
Title
Denominators
Categories
Title
Measurements
OG0003270± 64
OG0014320± 150
OG002NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG0034190± 52
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0034
Title
Denominators
Categories
Title
Measurements
OG00012.2± 64
OG0019.26± 150
OG002NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG00314.3± 52
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0031
Title
Denominators
Categories
Title
Measurements
OG0003.82± 60
OG0012.46± 46
OG002NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG0031.15± 57
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0035
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 2.0)
OG0012.00(2.0 to 6.0)
OG0022.00(2.0 to 24)
OG0034.00(2.0 to 6.0)
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0035
Title
Denominators
Categories
Title
Measurements
OG000527± 67
OG001609± 27
OG002168± 130
OG003363± 64
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0035
Title
Denominators
Categories
Title
Measurements
OG0005380± 50
OG0016540± 20
OG0022260± 70
OG0034160± 77
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
Title
Denominators
Categories
Title
Measurements
OG0004.00(0.5 to 6.0)
OG0012.00(2.0 to 4.0)
OG0024.00(2.0 to 6.0)
OG0035.00(0 to 6.0)
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
Title
Denominators
Categories
Title
Measurements
OG000508± 10
OG0011010± 27
OG002227± 19
OG003408± 62
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0034
Title
Denominators
Categories
Title
Measurements
OG0007000± 12
OG00113500± 39
OG002NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG0035410± 57
OG002
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0034
Title
Denominators
Categories
Title
Measurements
OG00018.6± 12
OG00113.3± 39
OG002NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG00333.3± 57
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG003
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0034
Title
Denominators
Categories
Title
Measurements
OG0001.30± 40
OG0012.06± 19
OG002NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG0031.36± 57
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0019
OG00212
OG0036
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 6.0)
OG0014.00(2.0 to 24)
OG0023.00(2.0 to 6.0)
OG0034.00(2.0 to 24)
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0019
OG00212
OG0036
Title
Denominators
Categories
Title
Measurements
OG00073.8± 38
OG00190.7± 87
OG002116± 63
OG00348.2± 97
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0019
OG00212
OG0036
Title
Denominators
Categories
Title
Measurements
OG0001080± 26
OG0011330± 100
OG0021790± 73
OG003700± 84
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0005
OG0018
OG0029
OG0032
Title
Denominators
Categories
Title
Measurements
OG0004.00(2.0 to 6.0)
OG0014.00(2.0 to 6.0)
OG0022.00(2.0 to 6.0)
OG003NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0005
OG0018
OG0029
OG0032
Title
Denominators
Categories
Title
Measurements
OG000119± 62
OG001237± 63
OG002254± 120
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0005
OG0018
OG0029
OG0032
Title
Denominators
Categories
Title
Measurements
OG0002200± 57
OG0014570± 68
OG0024700± 120
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0005
OG0018
OG0029
OG0032
Title
Denominators
Categories
Title
Measurements
OG00042.5(40 to 45)
OG00151.5(42 to 83)
OG00236.0(28 to 44)
OG003NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0005
OG0018
OG0029
OG0032
Title
Denominators
Categories
Title
Measurements
OG00018.2± 57
OG0018.76± 68
OG0028.52± 120
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0005
OG0018
OG0029
OG0032
Title
Denominators
Categories
Title
Measurements
OG0001.92± 51
OG0013.28± 52
OG0022.60± 63
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0019
OG00212
OG0036
Title
Denominators
Categories
Title
Measurements
OG0002.00(2.0 to 6.0)
OG0012.00(0.5 to 6.0)
OG0022.00(0.5 to 4.0)
OG0034.00(2.0 to 24)
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0019
OG00212
OG0036
Title
Denominators
Categories
Title
Measurements
OG000298± 52
OG001355± 55
OG002315± 58
OG003253± 90
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0019
OG00212
OG0036
Title
Denominators
Categories
Title
Measurements
OG0003010± 37
OG0013800± 63
OG0023210± 59
OG0033340± 78
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0018
OG00210
OG0032
Title
Denominators
Categories
Title
Measurements
OG0004.00(2.0 to 6.0)
OG0012.00(0.5 to 6.0)
OG0022.00(2.0 to 4.0)
OG003NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0018
OG00210
OG0032
Title
Denominators
Categories
Title
Measurements
OG000231± 63
OG001362± 60
OG002369± 66
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0018
OG00210
OG0032
Title
Denominators
Categories
Title
Measurements
OG0003390± 39
OG0015250± 66
OG0024580± 56
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00210
OG0031
Title
Denominators
Categories
Title
Measurements
OG000183(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG00128.5(22 to 33)
OG00226.6(20 to 37)
OG00330.9(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0018
OG00210
OG0032
Title
Denominators
Categories
Title
Measurements
OG00029.5± 39
OG00119.1± 66
OG00221.8± 56
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0004
OG0018
OG00210
OG0032
Title
Denominators
Categories
Title
Measurements
OG0000.90± 40
OG0011.39± 58
OG0021.43± 57
OG003NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00212
OG00312
OG0043
Title
Denominators
Categories
Title
Measurements
OG0004.00(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00212
OG00312
OG0043
Title
Denominators
Categories
Title
Measurements
OG000487± NAMeasure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00212
OG00312
OG0043
Title
Denominators
Categories
Title
Measurements
OG0006560± NAMeasure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG0004.00(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG0014.00(2.0 to 6.0)
OG0023.00(2.0 to 6.0)
OG0034.00(2.0 to 6.0)
OG004NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG000587± NAMeasure dispersion not applicable as only one participant was evaluable.
OG001502± 16
OG002469± 40
OG003393± 44
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG0009560± NAMeasure dispersion not applicable as only one participant was evaluable.
OG0017920± 16
OG0027390± 32
OG0035790± 46
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG00037.7(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG00138.6(33 to 42)
OG00250.2(35 to 89)
OG00342.6(27 to 64)
OG004NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG00013.1± NAMeasure dispersion not applicable as only one participant was evaluable.
OG00115.8± 16
OG00216.9± 32
OG00321.6± 46
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG0001.46± NAMeasure dispersion not applicable as only one participant was evaluable.
OG0011.43± 51
OG0021.89± 94
OG0031.72± 83
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00212
OG00312
OG0043
Title
Denominators
Categories
Title
Measurements
OG0002.00(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00212
OG00312
OG0043
Title
Denominators
Categories
Title
Measurements
OG000714± NAMeasure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0018
OG00212
OG00312
OG0043
Title
Denominators
Categories
Title
Measurements
OG0008050± NAMeasure dispersion not applicable as only one participant was evaluable.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG0002.00(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
OG0012.00(2.0 to 24)
OG0022.00(0.5 to 4.0)
OG0032.00(2.0 to 6.0)
OG004NA(NA to NA)As planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG000412± NAMeasure dispersion not applicable as only one participant was evaluable.
OG001518± 67
OG002520± 84
OG003334± 83
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG0006300± NAMeasure dispersion not applicable as only one participant was evaluable.
OG0016310± 31
OG0025930± 73
OG0033990± 74
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0000
OG0015
OG0028
OG0039
OG0041
Title
Denominators
Categories
Title
Measurements
OG00144.6(28 to 66)
OG00258.2(40 to 83)
OG00337.8(29 to 50)
OG00430.3(NA to NA)Measure dispersion not applicable as only one participant was evaluable.
Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG00028.6± NAMeasure dispersion not applicable as only one participant was evaluable.
OG00128.5± 31
OG00230.3± 73
OG00345.1± 74
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0001
OG0015
OG0028
OG0039
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000.78± NAMeasure dispersion not applicable as only one participant was evaluable.
OG0011.61± 110
OG0021.90± 50
OG0031.03± 84
OG004NA± NAAs planned, summary statistics were not derived if fewer than 3 participants had available data.
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG007
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG008
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG009
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
OG011
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG012
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG013
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG014
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG015
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG016
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG017
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG00331
OG00410
OG0058
OG0061
OG0072
OG0083
OG0094
OG01035
OG0117
OG0126
OG0133
OG0144
OG0153
OG0163
OG0173
Title
Denominators
Categories
PR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0091
OG0102
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
SD
Title
Measurements
OG0002
OG0012
OG0021
OG003
PD
Title
Measurements
OG0000
OG0011
OG0022
OG003
Unable to Evaluate
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG007
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG008
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG009
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
OG011
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG012
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG013
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG014
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG015
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG016
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG017
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG002
S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib
Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
OG004
S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG005
S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG006
S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib
Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG007
S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG008
S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG009
S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
OG011
S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG012
S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG013
S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib
Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG014
S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG015
S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG016
S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
OG017
S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib
Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.