A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And... | NCT01420081 | Trialant
NCT01420081
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Jan 8, 2019Actual
Enrollment
67Actual
Phase
Phase 2
Conditions
Endometrial Neoplasms
Interventions
PF-05212384
PF-05212384
PF-05212384
Countries
United States
Australia
Canada
Japan
Poland
Russia
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01420081
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1271004
Secondary IDs
ID
Type
Description
Link
2011-003062-32
EudraCT Number
Brief Title
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
Official Title
A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
See termination reason in detailed description.
Expanded Access Info
No
Start Date
Jan 19, 2012Actual
Primary Completion Date
Apr 30, 2014Actual
Completion Date
Dec 25, 2015Actual
First Submitted Date
Aug 17, 2011
First Submission Date that Met QC Criteria
Aug 17, 2011
First Posted Date
Aug 19, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 30, 2015
Results First Submitted that Met QC Criteria
Apr 30, 2015
Results First Posted Date
May 19, 2015Estimated
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
Dec 19, 2018
Last Update Posted Date
Jan 8, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
Detailed Description
The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The decision to terminate the study was made on January 23, 2014. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Conditions Module
Conditions
Endometrial Neoplasms
Keywords
uterine neoplasms
endometrial
uterine
cancer
PI3K
mTOR
PI3K/mTOR
recurrent
metastatic
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
67Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
B
Experimental
PI3K Basal, IV Compound
Drug: PF-05212384
C
Experimental
PI3K Activated, Oral Compound
Drug: PF-05212384
F
Experimental
Japanese lead in cohort, IV compound
Drug: PF-05212384
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-05212384
Drug
154mg IV weekly
B
PKI-587
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Clinical Benefit Response for PF-04691502
Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
16 weeks from Cycle 1 Day 1
Percentage of Participants With Clinical Benefit Response for PF-05212384
Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.
16 weeks from Cycle 1 Day 1
Secondary Outcomes
Measure
Description
Time Frame
Objective Response for PF-04691502
Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Recurrent endometrial carcinoma
Disease progression following one or two lines of prior treatment with platinum containing chemotherapy
Tumor tissue available at time of screening for PI3K analysis
Adequate performance status
Adequate glucose control, bone marrow, kidney, liver, and heart function
Exclusion Criteria:
More than 2 prior cytotoxic chemo regimens for endometrial carcinoma
Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor
Del Campo JM, Birrer M, Davis C, Fujiwara K, Gollerkeri A, Gore M, Houk B, Lau S, Poveda A, Gonzalez-Martin A, Muller C, Muro K, Pierce K, Suzuki M, Vermette J, Oza A. A randomized phase II non-comparative study of PF-04691502 and gedatolisib (PF-05212384) in patients with recurrent endometrial cancer. Gynecol Oncol. 2016 Jul;142(1):62-69. doi: 10.1016/j.ygyno.2016.04.019. Epub 2016 Apr 24.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
This study was conducted in parallel-arms in adult participants with recurrent endometrial cancer. Randomized arms included PF-05212384 (154mg dosage) and PF-04691502 (8mg which was lowered to 6mg) for both PI3K Basal or Activated. Lead-in Cohorts included PF-05212384 (89mg or 154mg) and PF-04691502 (4mg).
Recruitment Details
An open-label, Phase 2, four-arm, non-comparative study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-04691502 (an oral PI3K/mTOR inhibitor) and PF-05212384 (an Intravenous [IV] Phosphoinositide 3-Kinase [PI3K]/Mammalian Target of Rapamycin [mTOR] inhibitor).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-04691502 8 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, once daily (QD) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
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
Germany
Slovakia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel 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
PF-05212384
Drug
154mg IV weekly
C
PKI-587
PF-05212384
Drug
154mg IV weekly
F
PKI-587
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
Percentage of Participants With Objective Response for PF-05212384
Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
Progression Free Survival for PF-04691502
PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
Progression Free Survival for PF-05212384
PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384
Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.
6 months
Overall Survival (OS) for PF-05212384
OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.
12 months
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue
Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed.
Each slide was imaged by whole slide scanning and patient samples were scored as follows:
Pathologist manual score (0, 1+, 2+, 3+) for overall staining intensity of tumor tissue.
Percentage of positive tumor cells staining at 0, 1+, 2+, and 3+.
H-score value (integer between 0 and 300) for tumor cell staining was calculated. The higher the stathmin staining, the higher the stathmin H-score.
Prior to Cycle 1 Day 1
Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers- PIK3CA Amplification, KRAS Mutation P/N, KRAS Mutation OBSV, PTEN Stroma Manual Score, PTEN Tumor Manual Score, KRAS SCC and Stathmin H/L,Tissue.
Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, Phosphatase And Tensin Homolog (PTEN) protein levels, and PIK3CA gene amplification were to be assessed.
Stained tissues were evaluated by a board-certified pathologist who provided a manual pathology score (i.e., 0, 1+, 2+, or 3+) and, if appropriate, comments upon the staining of the specimen.
The directionality increases from 0 to 3+ with 0 being no staining for PTEN by IHC and 3+ being high staining intensity for PTEN.
Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days
Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Clearance (CL) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours
Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities
Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
From baseline (-3 days) until 35 days post last dose
Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities
Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
From baseline (-3 days) until 35 days post last dose
Number of Treatment-related TEAEs
Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
From baseline (-3 days) until 35 days post last dose
Summary of Treatment-related TEAEs
Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
From baseline (-3 days) until 35 days post last dose
Birmingham
Alabama
35249
United States
University of Alabama at Birmingham
Birmingham
Alabama
35249
United States
University of California Medical Center
La Jolla
California
92037
United States
Moores UC San Diego Cancer Center
La Jolla
California
92093
United States
University of California Medical Center
San Diego
California
92103
United States
Mercy Hospital
Miami
Florida
33133
United States
Mercy Research Institute
Miami
Florida
33133
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
University of Chicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox
Illinois
60451
United States
University of Kansas
Fairway
Kansas
66205
United States
University of Kansas Hospital
Kansas City
Kansas
66160
United States
University of Kansas Cancer Center and Medical Pavilion
Westwood
Kansas
66205
United States
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital
Covington
Louisiana
70433
United States
Women's Cancer Care
Covington
Louisiana
70433
United States
Women's Cancer Care
Metairie
Louisiana
70006
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
University of New Mexico Cancer Center
Albuquerque
New Mexico
87106
United States
Peter MacCallum Cancer Centre, Division of Cancer Madicine
East Melbourne
Victoria
3002
Australia
Foothills Medical Center
Calgary
Alberta
T2N 2T9
Canada
Tom Baker Cancer Centre
Calgary
Alberta
T2N 4N2
Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver
British Columbia
V5Z 4E6
Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston
Ontario
K7L 5P9
Canada
Princess Margaret Hospital
Toronto
Ontario
M5G 2M9
Canada
Royal Victoria Hospital
Montreal
Quebec
H3A 1A1
Canada
Jewish General Hospital
Montreal
Quebec
H3T 1E2
Canada
St. Mary's Hospital
Montreal
Quebec
H3T 1M5
Canada
Aichi cancer center hospital
Nagoya
Aichi-ken
464-8681
Japan
Hyogo Cancer Center
Akashi
Hyōgo
673-8558
Japan
Saitama Medical University International Medical Center
Hidaka
Saitama
350-1298
Japan
National Cancer Center Hospital
Chuo-Ku
Tokyo
104-0045
Japan
Regionalny Osrodek Onkologiczny Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz
93-509
Poland
Zaklad Radiologii
Lodz
93-513
Poland
Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli
Lublin
20-090
Poland
Federal State Healthcare Institution
Lermontov
Stavropol Territory
357340
Russia
Clinical Oncology Dispensary 1 of Department of Healthcare of the Krasnodar Region
Krasnodar
350040
Russia
Pyatigorsk Oncology Center
Pyatigorsk
357502
Russia
Saint Petersburg State Healthcare Institution City Clinical Oncology Dispensary
Saint Petersburg
198255
Russia
Hospital Universitari Vall d'hebron
Barcelona
08035
Spain
Centro Oncologico MD Anderson Internacional España
Madrid
28033
Spain
Hospital Clinico San Carlos
Madrid
28040
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Fundacion Instituto Valenciano de Oncologia - I.V.O.
Valencia
46009
Spain
Fundacion Instituto Valenciano de Oncologia - I.V.O
Valencia
46009
Spain
The Royal Marsden NHS Foundation Trust
Sutton
Surrey
SM2 5PT
United Kingdom
Beatson Oncology Centre
Glasgow
G12 0YN
United Kingdom
University College London Hospital NHS Foundation Trust
London
NW1 2PG
United Kingdom
The Royal Marsden NHS Foundation Trust
London
SW3 6JJ
United Kingdom
FG001
PF-04691502 6 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG002
PF-04691502 8 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
FG003
PF-04691502 6 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG004
PF-05212384 154 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, once weekly (Quaque, QW) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG005
PF-05212384 154 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG006
Lead-in-cohort (LIC) PF-04691502 (4 mg)
Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG007
LIC PF-05212384 (89 mg)
Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG008
LIC PF-05212384 (154 mg)
Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
FG0003 subjects
FG0011 subjects
FG00211 subjects
FG0033 subjects
FG00420 subjects
FG00520 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG00211 subjects
FG0033 subjects
FG00420 subjects
FG00520 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0028 subjects
FG0030 subjects
FG0047 subjects
FG00512 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG004
Subject Refused Futher Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other Reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-04691502 8 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
BG001
PF-04691502 6 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG002
PF-04691502 8 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
BG003
PF-04691502 6 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG004
PF-05212384 154 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG005
PF-05212384 154 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG006
Lead-in-cohort (LIC) PF-04691502 (4 mg)
Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG007
LIC PF-05212384 (89 mg)
Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG008
LIC PF-05212384 (154 mg)
Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0011
BG00211
BG0033
BG00420
BG00520
BG0063
BG0073
BG0083
BG00967
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
< 18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
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
Clinical Benefit Response for PF-04691502
Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Number
Participants
16 weeks from Cycle 1 Day 1
ID
Title
Description
OG000
PF-04691502 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
OG001
PF-04691502 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
Units
Counts
Participants
OG0004
OG00111
Title
Denominators
Categories
Participants with "Yes" response
Title
Measurements
OG0001
OG0010
Participants with "No" response
Title
Measurements
OG000
Primary
Percentage of Participants With Clinical Benefit Response for PF-05212384
Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Number
95% Confidence Interval
Percentage of participants
16 weeks from Cycle 1 Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
Secondary
Objective Response for PF-04691502
Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Number
Participants response
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
ID
Title
Description
OG000
PF-04691502 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
OG001
PF-04691502 (PI3K Activated)
Secondary
Percentage of Participants With Objective Response for PF-05212384
Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Number
95% Confidence Interval
Percentage of participants
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Progression Free Survival for PF-04691502
PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Number
Time to Event (Days)
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
ID
Title
Description
OG000
PF-04691502 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
OG001
PF-04691502 (PI3K Activated)
Secondary
Progression Free Survival for PF-05212384
PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Median
95% Confidence Interval
Days
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384
Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.
Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
Number
95% Confidence Interval
Percentage of participants
6 months
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Overall Survival (OS) for PF-05212384
OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.
Survival analysis was not performed as the study was terminated early. No data are available because data were not collected. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.
Posted
12 months
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.
Posted
Mean
Standard Deviation
Glucose (mg/dL)
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
Secondary
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.
Posted
Mean
Standard Deviation
Insulin (UIU/mL)
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
Secondary
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.
Posted
Mean
Standard Deviation
HbA1c (mg/dL)
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
Secondary
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.
Posted
Mean
Standard Deviation
Cholesterol (mg/dL)
Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
Secondary
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)
PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.
Posted
Mean
Standard Deviation
Triglycerides (mg/dL)
Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
Secondary
Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue
Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed.
Each slide was imaged by whole slide scanning and patient samples were scored as follows:
Pathologist manual score (0, 1+, 2+, 3+) for overall staining intensity of tumor tissue.
Percentage of positive tumor cells staining at 0, 1+, 2+, and 3+.
H-score value (integer between 0 and 300) for tumor cell staining was calculated. The higher the stathmin staining, the higher the stathmin H-score.
Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.
Posted
Mean
Standard Deviation
Score
Prior to Cycle 1 Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers- PIK3CA Amplification, KRAS Mutation P/N, KRAS Mutation OBSV, PTEN Stroma Manual Score, PTEN Tumor Manual Score, KRAS SCC and Stathmin H/L,Tissue.
Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, Phosphatase And Tensin Homolog (PTEN) protein levels, and PIK3CA gene amplification were to be assessed.
Stained tissues were evaluated by a board-certified pathologist who provided a manual pathology score (i.e., 0, 1+, 2+, or 3+) and, if appropriate, comments upon the staining of the specimen.
The directionality increases from 0 to 3+ with 0 being no staining for PTEN by IHC and 3+ being high staining intensity for PTEN.
Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.
Posted
Number
Percentage of participants
Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Secondary
Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.hr/mL
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
Secondary
Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.hr/mL
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
Secondary
Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG000
Secondary
Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Mean
Standard Deviation
hours
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG000
Secondary
Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Median
Full Range
hours
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG000
Secondary
Clearance (CL) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG000
Secondary
Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.
Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG000
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities
Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.
Posted
Number
Number of AEs
From baseline (-3 days) until 35 days post last dose
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities
Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.
Posted
Number
Number of participants
From baseline (-3 days) until 35 days post last dose
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Number of Treatment-related TEAEs
Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.
Posted
Number
Number of AEs
From baseline (-3 days) until 35 days post last dose
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Secondary
Summary of Treatment-related TEAEs
Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.
Posted
Number
Number of participants
From baseline (-3 days) until 35 days post last dose
ID
Title
Description
OG000
PF-05212384 (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG001
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Time Frame
Maximum of treatment duration (i.e., 21 to 169 days for the PF 04691502 [PI3K basal and activated], 29 to 345 days for PF 05212384 PI3K basal and 1 to 400 days for PF 05212384 PI3K activated) + 28 days across all participants.
Description
There are inconsistency with the number of paticipants per arm in 'Participant flow section' and 'AE section' (both tables). This was because one participant treated with PF-05212384 and two subjects treated with PF-04691502 had their stathmin status changed after randomization and are categorized under the corresponding arm.
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
PF-04691502 8 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
3
5
5
5
EG001
PF-04691502 6 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
1
1
1
1
EG002
PF-04691502 8 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
7
9
9
9
EG003
PF-04691502 6 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
1
3
3
3
EG004
PF-05212384 154 mg (PI3K Basal)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW (Quaque [Once Weekly]) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
3
21
21
21
EG005
PF-05212384 154 mg (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
10
19
18
19
EG006
Lead-in-cohort (LIC) PF-04691502 (4 mg)
Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
1
3
3
3
EG007
LIC PF-05212384 (89 mg)
Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
0
3
3
3
EG008
LIC PF-05212384 (154 mg)
Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac Failure
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG0030 affected3 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Large Intestinal Obstruction
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Oral Pain
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0021 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Chills
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Disease Progression
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lung Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Skin Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Gastric Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Acute Respiratory Distress Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Pneumothorax Spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0020 affected9 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0021 affected9 at risk
EG0030 affected3 at risk
EG0042 affected21 at risk
EG0052 affected19 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected3 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
External Ear Inflammation
Ear and labyrinth disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Abnormal Sensation In Eye
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Eyelid Bleeding
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Iritis
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Vision Blurred
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Visual Impairment
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Aphthous Stomatitis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0023 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0004 affected5 at risk
EG0010 affected1 at risk
EG0027 affected9 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0011 affected1 at risk
EG0022 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypoaesthesia Oral
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lip Ulceration
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected5 at risk
EG0011 affected1 at risk
EG0025 affected9 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oral Discomfort
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oral Dysaesthesia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oral Pain
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0024 affected9 at risk
EG003
Tooth Disorder
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Asthenia
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0023 affected9 at risk
EG003
Catheter Site Bruise
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Catheter Site Oedema
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Catheter Site Pain
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Chills
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Fatigue
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected5 at risk
EG0010 affected1 at risk
EG0026 affected9 at risk
EG003
Gait Disturbance
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Influenza Like Illness
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Infusion Site Extravasation
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Infusion Site Rash
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Malaise
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Medical Device Complication
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Mucosal Dryness
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0023 affected9 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oedema
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oedema Peripheral
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Pain
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Candida Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Cystitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Genital Herpes Zoster
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Oral Fungal Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Paronychia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Skin Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Vulvitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Vascular Access Complication
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Blood Alkaline Phosphatase
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Blood Creatinine
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Blood Magnesium Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Blood Pressure Diastolic Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Chest X-Ray Abnormal
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Electrocardiogram Qt Prolonged
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Glycosylated Haemoglobin Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Haemoglobin
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0020 affected9 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0011 affected1 at risk
EG0021 affected9 at risk
EG003
Weight Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0020 affected9 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0026 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0005 affected5 at risk
EG0010 affected1 at risk
EG0027 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0011 affected1 at risk
EG0024 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0024 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Inguinal Mass
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oncologic Complication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Ageusia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Amnesia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Bradyphrenia
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Delirium
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Dysthymic Disorder
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hallucination, Visual
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Irritability
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Vulvovaginal Discomfort
Reproductive system and breast disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0023 affected9 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hangnail
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0023 affected9 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pain Of Skin
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected5 at risk
EG0010 affected1 at risk
EG0022 affected9 at risk
EG003
Rash Generalised
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Skin Disorder
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Swelling Face
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected1 at risk
EG0020 affected9 at risk
EG003
Haematoma
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hot Flush
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pallor
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Phlebitis
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0021 affected9 at risk
EG003
Dry Eyes
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Noninfective Gingivitis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected1 at risk
EG0020 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D016889
Endometrial Neoplasms
D014594
Uterine Neoplasms
D009369
Neoplasms
D012008
Recurrence
D009362
Neoplasm Metastasis
Ancestor Terms
ID
Term
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D009385
Neoplastic Processes
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C549060
gedatolisib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
11 subjects
FG0057 subjects
FG0063 subjects
FG0072 subjects
FG0082 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
18 - 44 years
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
45 - 64 years
Title
Measurements
BG0002
BG0011
BG0024
BG0033
BG0049
BG0054
BG0062
BG0071
BG0082
BG00928
>= 65 years
Title
Measurements
BG0001
BG0010
BG0027
BG0030
BG00411
BG00516
BG0061
BG0071
BG0081
BG00938
11
BG0033
BG00420
BG00520
BG0063
BG0073
BG0083
BG00967
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
3
OG00111
PF-05212384 (PI3K Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00010
OG0015
OG00215
Title
Denominators
Categories
Title
Measurements
OG00052.6(28.9 to 75.6)
OG00126.3(9.1 to 51.2)
OG00239.5(24.0 to 56.6)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
Units
Counts
Participants
OG0004
OG00111
Title
Denominators
Categories
Participants with "Yes" response
Title
Measurements
OG0000
OG0010
Participants with "No" response
Title
Measurements
OG0004
OG00111
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00019
OG00119
OG00238
Title
Denominators
Categories
Title
Measurements
OG00021.1(6.1 to 45.6)
OG00115.8(3.4 to 39.6)
OG00218.4(7.7 to 34.3)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
Units
Counts
Participants
OG0004
OG00111
Title
Denominators
Categories
Participant 1
Title
Measurements
OG0001
OG0010
Participant 2
Title
Measurements
OG000108
OG0010
Participant 3
Title
Measurements
OG00050
OG0010
Participant 4
Title
Measurements
OG000199
OG0010
Participant 5
Title
Measurements
OG0000
OG00154
Participant 6
Title
Measurements
OG0000
OG00155
Participant 7
Title
Measurements
OG0000
OG00151
Participant 8
Title
Measurements
OG0000
OG0011
Participant 9
Title
Measurements
OG0000
OG00154
Participant 10
Title
Measurements
OG0000
OG00162
Participant 11
Title
Measurements
OG0000
OG00153
Participant 12
Title
Measurements
OG0000
OG001105
Participant 13
Title
Measurements
OG0000
OG0011
Participant 14
Title
Measurements
OG0000
OG00154
Participant 15
Title
Measurements
OG0000
OG00154
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00019
OG00119
OG00238
Title
Denominators
Categories
Title
Measurements
OG000112.0(59.0 to 167.0)
OG00189.0(56.0 to 172.0)
OG002108.0(62.0 to 149.0)
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00019
OG00119
OG00238
Title
Denominators
Categories
Title
Measurements
OG00023.2(7.3 to 44.1)
OG00125.0(7.8 to 47.2)
OG00224.3(11.6 to 39.5)
Units
Counts
Participants
OG0000
OG0010
OG0020
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00018
OG00118
OG00236
Title
Denominators
Categories
Baseline
Title
Measurements
OG00098.5± 12.76
OG001101.7± 26.56
OG002100.1± 20.60
Cycle 1 Day 15 (n=18,17,35)
Title
Measurements
OG000105.3± 18.44
OG001117.2± 61.04
OG002111.1± 44.26
Cycle 1 Day 22 (n=2,1,3)
Title
Measurements
OG000103.0± 16.34
OG001120.1± 0
OG002108.7± 15.19
Cycle 2 Day 1 (n=17,14,31)
Title
Measurements
OG000103.7± 19.31
OG001114.0± 39.42
OG002108.3± 29.99
Cycle 2 Day 15 (n=17,8,25)
Title
Measurements
OG000104.8± 13.94
OG001106.4± 19.36
OG002105.3± 15.47
Cycle 3 Day 1 (n=14,10,24)
Title
Measurements
OG000100.6± 16.29
OG001125.9± 74.50
OG002111.1± 49.85
Cycle 4 Day 1 (n=12,7,19)
Title
Measurements
OG00096.3± 10.40
OG00198.9± 10.20
OG00297.3± 10.12
Cycle 5 Day 1 (n=9,4,13)
Title
Measurements
OG000103.2± 15.17
OG001112.2± 24.37
OG002106.0± 17.90
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00017
OG00114
OG00231
Title
Denominators
Categories
Baseline
Title
Measurements
OG00015.2± 12.68
OG00114.4± 7.03
OG00214.8± 10.36
Cycle 1 Day 15 (n=16,12,28)
Title
Measurements
OG00023.6± 14.69
OG00135.9± 37.05
OG00228.9± 26.79
Cycle 1 Day 22 (n=2,1,3)
Title
Measurements
OG00057.6± 51.18
OG00129.1± 0
OG00248.1± 39.75
Cycle 2 Day 1 (n=17,10,27)
Title
Measurements
OG00030.3± 28.92
OG00128.9± 27.85
OG00229.8± 27.99
Cycle 2 Day 15 (n=14,6,20)
Title
Measurements
OG00028.2± 29.56
OG00121.9± 10.49
OG00226.3± 25.21
Cycle 3 Day 1 (n=13,9,22)
Title
Measurements
OG00020.7± 13.65
OG00135.1± 38.66
OG00226.6± 26.99
Cycle 4 Day 1 (n=11,6,17)
Title
Measurements
OG00017.1± 10.04
OG00124.8± 32.32
OG00219.8± 20.10
Cycle 5 Day 1 (n=7,4,11)
Title
Measurements
OG00017.0± 15.56
OG00115.7± 6.20
OG00216.5± 12.54
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00018
OG00118
OG00236
Title
Denominators
Categories
Baseline (n=15,14,29)
Title
Measurements
OG0007.8± 8.58
OG0017.5± 6.15
OG0027.7± 7.37
Cycle 1 Day 15 (n=4,2,6)
Title
Measurements
OG00014.7± 19.00
OG0017.1± 1.34
OG00212.2± 15.25
Cycle 2 Day 1 (n=15,13,28)
Title
Measurements
OG0008.4± 9.66
OG0016.7± 1.16
OG0027.6± 7.05
Cycle 2 Day 15 (n=3,0,3)
Title
Measurements
OG0006.7± 0.71
OG001NA± NANone of the participants were analyzed for arm PF-05212384 (PI3K activated) and hence data is not available.
OG0026.7± 0.71
Cycle 3 Day 1 (n=10,4,14)
Title
Measurements
OG0006.0± 0.78
OG0017.3± 1.70
OG0026.4± 1.19
Cycle 4 Day 1 (n=12,7,19)
Title
Measurements
OG0008.9± 10.13
OG0016.9± 1.05
OG0028.2± 8.01
Cycle 5 Day 1 (n=8,2,10)
Title
Measurements
OG0005.9± 0.89
OG00131.5± 36.06
OG00211.0± 16.17
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00018
OG00118
OG00236
Title
Denominators
Categories
Baseline (n=11,4,15)
Title
Measurements
OG000213± 54.48
OG001186.5± 52.43
OG002205.9± 53.45
Cycle 1 Day 28 (n=15,7,22)
Title
Measurements
OG000214.9± 49.15
OG001161.6± 86.51
OG002198.0± 66.28
Cycle 2 Day 28 (n=16,6,22)
Title
Measurements
OG000229.8± 44.31
OG001127.9± 108.69
OG002202.0± 79.83
Cycle 3 Day 28 (n=11,4,15)
Title
Measurements
OG000230.5± 48.63
OG001137.6± 107.02
OG002205.7± 77.15
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00018
OG00118
OG00236
Title
Denominators
Categories
Baseline (n=11,4,15)
Title
Measurements
OG000104.2± 40.95
OG001133.4± 25.75
OG002112.0± 38.96
Cycle 1 Day 28 (n=15,7,22)
Title
Measurements
OG000136.9± 70.03
OG001134.5± 57.21
OG002136.1± 64.85
Cycle 2 Day 28 (n=16,6,22)
Title
Measurements
OG000133.2± 71.40
OG001117.1± 62.77
OG002128.8± 68.07
Cycle 3 Day 28 (n=10,4,14)
Title
Measurements
OG000119.9± 64.22
OG001130.4± 58.01
OG002122.9± 60.47
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
Units
Counts
Participants
OG00021
OG00119
OG00240
Title
Denominators
Categories
Title
Measurements
OG00096.4± 33.76
OG001201.3± 34.87
OG002146.2± 62.9
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
OG002
PF-05212384 (PI3K Basal + Activated)
Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.