CGT9486 (Formerly Known as PLX9486) as a Single Agent and... | NCT02401815 | Trialant
NCT02401815
Sponsor
Cogent Biosciences, Inc.
Status
Completed
Last Update Posted
Feb 14, 2025Actual
Enrollment
51Actual
Phase
Phase 1Phase 2
Conditions
Gastrointestinal Stromal Tumors
Interventions
CGT9486
Pexidartinib
Sunitinib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02401815
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PLX121-01
Secondary IDs
Not provided
Brief Title
CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors
Official Title
A Phase 1b and 2a Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CGT9486 as a Single Agent and in Combination With PLX3397 or Sunitinib (Sutent®) in Patients With Advanced Solid Tumors and Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor (GIST) Who Have Been Previously Treated With Imatinib Mesylate/KIT-Directed Tyrosine Kinase Inhibitor (TKI) Therapy
Acronym
Not provided
Organization
Cogent Biosciences, Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 6, 2015Actual
Primary Completion Date
May 11, 2020Actual
Completion Date
May 11, 2020Actual
First Submitted Date
Mar 19, 2015
First Submission Date that Met QC Criteria
Mar 27, 2015
First Posted Date
Mar 30, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 22, 2024
Results First Submitted that Met QC Criteria
Jan 24, 2025
Results First Posted Date
Feb 14, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 30, 2021
Certification/Extension First Submitted that Passed QC Review
Apr 30, 2021
Certification/Extension First Posted Date
May 4, 2021Actual
Last Update Submitted Date
Jan 24, 2025
Last Update Posted Date
Feb 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Cogent Biosciences, Inc.INDUSTRY
Collaborators
Name
Class
Plexxikon
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
The goal of this clinical research study is to learn how CGT9486 (fka PLX9486) may affect cancer cells with certain mutations in the KIT gene, specifically in participants with types of advanced solid tumors including gastrointestinal stromal tumor (GIST).
CGT9486 (fka PLX9486) is designed to block KIT gene mutations. These mutations can cause cancer and cancer cell growth. By blocking these mutations, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing. By combining CGT9486 (fka PLX9486) with PLX3397 and CGT9486 (fka PLX9486) with sunitinib, the investigators hope to block most KIT gene mutations that drive cancer growth.
Detailed Description
This study includes a dose escalation portion (Part 1) in which the safety profile and recommended phase 2 dose (RP2D) of CGT9486 as a single oral agent will be evaluated in participants with solid tumors (including GIST), followed by signal-seeking extension cohorts (Part 2). Enrollment in the combination treatment portions of the study (dose-finding for the CGT9486 + pexidartinib combination [Part 2b] and the CGT9486 + sunitinib combination [Part 2e]) is planned to be accrued using standard 3+3 study designs.
Parts 2a, 2c, 2d, and 2f are not conducted due to business decisions.
Conditions Module
Conditions
Gastrointestinal Stromal Tumors
Keywords
Gastrointestinal Stromal Tumors
KIT
Biomarkers
PLX9486
PLX3397
Sunitinib
CGT9486
GIST
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
51Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: CGT9486 250 mg QD
Experimental
Participants will receive CGT9486 250 milligrams (mg) orally once daily (QD) in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Part 1: CGT9486 350 mg QD
Experimental
Participants will receive CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Part 1: CGT9486 500 mg QD
Experimental
Participants will receive CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Part 1: CGT9486 1000 mg QD
Experimental
Participants will receive CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Part 1: CGT9486 500 mg BID
Experimental
Participants will receive CGT9486 500 mg orally twice daily (BID) in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CGT9486
Drug
CGT9486 will be administered per dose and schedule specified in the arm.
Part 1: CGT9486 1000 mg QD
Part 1: CGT9486 250 mg QD
Part 1: CGT9486 350 mg QD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Recommended Phase 2 Dose (RP2D) of CGT9486
RP2D was determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) V4.03. DLTs: AEs that occurred during Cycle 1, possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for >7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for >7 days, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.
Cycle 1 of Part 1 (Cycle length = 28 days)
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A treatment-emergent AE (TEAE) was an AE that started or worsened in severity on or after the date of the initial dose of study drug. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days)
Part 1: Area Under The Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24) of CGT9486
AUC0-24 was determined by the linear trapezoidal rule for the ascending portion and by the log trapezoidal rule for the descending portion of the plasma profile. For BID dosing, Cycle 1 Day 15 AUC0-24 was calculated as 2 x area under the concentration time curve from time zero to 12 hours after dosing (AUC0-12). Missing concentration data were excluded from Pharmacokinetic (PK) analysis.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Overall Response Rate (ORR): Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed Using RECIST V1.1
ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female ≥18 years old.
Part 1, Part 2b, Part 2d, and Part 2e: Participants with advanced solid tumors who have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy.
Part 2d: Participants with non GIST solid tumors with KIT mutations, who are TKI naïve or have been previously treated with KIT directed TKI therapy who are appropriate for KIT directed TKI therapy
Part 2a, Part 2c, and Part 2f (GIST participants): Histologically confirmed locally advanced, metastatic and/or unresectable GIST.
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (≤7 days prior to the first dose of study drug) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug.
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤ Grade 1 or Baseline) prior to study treatment administration.
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Life expectancy ≥3 months.
Adequate hematologic, hepatic, and renal function:
Left ventricular ejection fraction (LVEF) >50% per echocardiogram (ECHO) or multiple-gated acquisition (MUGA) for participants on the sunitinib arms (Parts 2e and f).
Exclusion Criteria:
Known or demonstrated wild type KIT or platelet-derived growth factor receptors (PDGF-R), or known or demonstrated mutations of PDGF R, sorbitol dehydrogenase (SDH), or neurofibromin 1 (NF 1) that are causative for the observed malignancy.
For Part 1 (phase 1, single agent): Participants with a known or presumed pathogenic KIT exon 13 or 14 resistance mutation.
Parts 2a and 2d: Participants with known or presumed pathogenic KIT exon 13 or 14 resistance mutations. (However, such participants are permitted on the combination arms of Parts 2b, 2c, 2e, or 2f.)
Presence of symptomatic or uncontrolled brain or central nervous system metastases. Participants with stable, treated brain metastases are eligible for this trial. However, participants must not have required steroid treatment for their brain metastases within 30 days of Screening.
Known or suspected allergy to the investigational agent or any agent given in association with this trial.
Clinically significant cardiac disease
Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
Ongoing infection of ≥ Grade 2 severity.
Non-healing wound, ulcer, or bone fracture.
Known human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy, participants with known active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
Hepatobiliary diseases including biliary tract diseases, autoimmune hepatitis, inflammation, fibrosis, or cirrhosis of liver caused by viral, alcohol, or genetic reasons. Gilbert's disease is allowed if total bilirubin is ≤1.5 * upper limit of normal (ULN).
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
Females who are pregnant or nursing.
Any psychological, familial, sociological, or geographical condition that could hamper compliance with the study protocol.
Strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives of the agent, whichever is longer, of study drug initiation or the need to continue these drugs during this study.
Major surgery or significant traumatic injury within 14 days of Cycle 1 Day 1.
History (within 2 years prior to first study drug administration) of another malignancy unless the malignancy was treated with curative intent and likelihood of relapse is small (<5% in 2 years in the judgment of the investigator).
Anti-cancer therapy within the period immediately before Cycle 1 Day 1
Wagner AJ, Severson PL, Shields AF, Patnaik A, Chugh R, Tinoco G, Wu G, Nespi M, Lin J, Zhang Y, Ewing T, Habets G, Burton EA, Matusow B, Tsai J, Tsang G, Shellooe R, Carias H, Chan K, Rezaei H, Sanftner L, Marimuthu A, Spevak W, Ibrahim PN, Inokuchi K, Alcantar O, Michelson G, Tsiatis AC, Zhang C, Bollag G, Trent JC, Tap WD. Association of Combination of Conformation-Specific KIT Inhibitors With Clinical Benefit in Patients With Refractory Gastrointestinal Stromal Tumors: A Phase 1b/2a Nonrandomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1343-1350. doi: 10.1001/jamaoncol.2021.2086.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 51 participants were enrolled; 24 participants were enrolled across 5 cohorts in Part 1, 12 participants were enrolled across 2 cohorts in Part 2b, and 18 participants (including 3 "re-enrolled") were enrolled across 3 cohorts in Part 2e. 1 participant enrolled in Part 1 and 2 participants enrolled in Part 2b and subsequently were re-enrolled in Part 2e with new identification numbers unique to Part 2e. Participant numbers were not reassigned or reused.
Recruitment Details
This study included a dose escalation portion (Part 1) in which the safety profile and recommended phase 2 dose (RP2D) of CGT9486 as a single oral agent was evaluated in participants with solid tumors (including gastrointestinal stromal tumor [GIST]), followed by signal-seeking extension cohorts of CGT9486 in combination with pexidartinib or sunitinib (Part 2). Parts 2a, 2c, 2d, and 2f were not conducted due to business decisions.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 milligrams (mg) orally once daily (QD) in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in fasting condition will receive CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition will receive CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Drug: Pexidartinib
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Experimental
Participants will receive CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Drug: Sunitinib
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Experimental
Participants will receive CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Drug: CGT9486
Drug: Sunitinib
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Experimental
Participants will receive CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment will continue until participant discontinuation, withdrawal, or study termination.
Sunitinib will be administered per dose and schedule specified in the arm.
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Part 1: Maximum Observed Plasma Concentration (Cmax) of CGT9486
Cmax was taken directly from bioanalytical data.
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Part 1: Time to Reach Cmax (Tmax) of CGT9486
Tmax was taken directly from merged clinical and bioanalytical data, with time presented as nominal time relative to dose.
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 (Day -10 for 350 mg QD cohort) and Cycle 1 Day 15
Part 1: Half Life (T1/2) of PLX9486
Participants in a selected Part 1 cohort (350 mg QD) participated in a PK substudy to obtain more complete information on the PK profile of PLX9486. Participants received a single dose of 350 mg of PLX9486 10 days prior to the start of repeated QD dosing and plasma concentrations were followed 0.5, 1, 2, 4, 6, and 9 hours postdose, and then once daily for 9 additional days prior to Cycle 1 Day 1.
Predose, 0.5, 1, 2, 4, 9, 24, 49, 72, 96, 120, 144, 168, 192, 216 hours postdose on Day -10
Part 2e: RP2D of CGT9486 in Combination With Sunitinib
RP2D was determined by incidence of DLT using CTCAE version 4.03 for severity grade. DLTs were defined as AEs that occurred during Cycle 1, classified as possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for >7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for >7 days or with bleeding, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for the following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.
Cycle 1 of Part 2e (Cycle length = 28 days)
Part 2b: RP2D of PLX9486 in Combination With Pexidartinib
RP2D was determined by incidence of DLT using CTCAE version 4.03 for severity grade. DLTs were defined as AEs that occurred during Cycle 1, classified as possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for >7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for >7 days or with bleeding, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for the following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.
Cycle 1 of Part 2 b (Cycle length = 28 days)
Part 2b: Number of Participants With Any TEAEs and Treatment-Related TEAEs
An AE was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A TEAE was an AE that started or worsened in severity on or after the date of the initial dose of study drug. Treatment-related TEAEs included all events reported as "possibly related" or "probably related" to any of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 868 days)
Part 2e: Number of Participants With Any TEAEs and Treatment-Related TEAEs
An AE was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A TEAE was an AE that started or worsened in severity on or after the date of the initial dose of study drug. Treatment-related TEAEs included all events reported as "possibly related" or "probably related" to any of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 825 days)
From the date of first dose of study drug until the first appearance of CR or PR (maximum exposure: 670 days)
Part 1: Progression-Free Survival (PFS), as Assessed Using RECIST V1.1
PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
From the first date of treatment until the first documented disease progression or date of death (maximum exposure: 670 days)
Part 1: Duration of Response (DOR), as Assessed Using RECIST V1.1
DOR was defined as the number of days from the date of first response (PR or CR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
From the date of first response (PR or CR) to the date of first documented disease progression/relapse or death, whichever occurred first (maximum exposure: 670 days)
Part 2: Overall Response Rate (ORR): Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed Using RECIST V1.1
ORR was defined as the percentage of participants who achieved a best overall response of confirmed CR or PR. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From the date of first dose of study drug until the first appearance of CR or PR (maximum exposure: 868 days)
Part 2: Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit, as Assessed Using RECIST V1.1
Participants were considered to experience clinical benefit if they had a best overall response of stable disease (SD) that lasted for at least 16 weeks, or confirmed best overall response of PR or CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters. CR: Disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression.
From the date of first dose of study drug until the first appearance of CR, PR, or SD (maximum exposure: 868 days)
Part 2: Progression-Free Survival (PFS), as Assessed Using RECIST V1.1
PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
From the first date of treatment until the first documented disease progression or date of death (maximum exposure: 868 days)
Part 2: Overall Survival
Overall Survival was defined as the number of days from the first day of treatment (Cycle 1 Day 1) until the date of death. If a participant was lost to follow-up, overall survival was censored at the date of last contact. Median was calculated using Kaplan-Meier estimate.
From the first day of treatment until the date of death (maximum exposure: 868 days)
Part 2: Overall Survival at Month 12
Percentage of participants who survived at Month 12 have been reported.
Month 12
Part 2: PFS at Month 6
PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Percentage of participants with PFS at Month 6 are reported.
Month 6
Part 2: Duration of Response (DOR), as Assessed Using RECIST V1.1
DOR was defined as the number of days from the date of first response (PR or CR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
From the date of first response (PR or CR) to the date of first documented disease progression/relapse or death, whichever occurred first (maximum exposure: 868 days)
Part 2: AUC0-24 of CGT9486 in Combination With Pexidartinib or Sunitinib
AUC0-24 was determined by the linear trapezoidal rule for the ascending portion and by the log trapezoidal rule for the descending portion of the plasma profile. Missing concentration data were excluded from PK analysis.
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Part 2: Cmax of CGT9486 in Combination With Pexidartinib or Sunitinib
Cmax was taken directly from bioanalytical data.
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Part 2: Tmax of CGT9486 in Combination With Pexidartinib or Sunitinib
Tmax was taken directly from merged clinical and bioanalytical data, with time presented as nominal time relative to dose.
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Boston
Massachusetts
02115
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
48109
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
OSU Comprehensive Cancer Center
Columbus
Ohio
43210
United States
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally twice daily (BID) in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG007
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG008
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG009
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0047 subjects1 participant enrolled in Part 1 and subsequently re-enrolled in Part 2e.
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Received at Least 1 Dose of Study Drug
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0047 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0047 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Clinical Progression
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0035 subjects
FG004
Progressive Disease (Per RECIST)
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dose Extension Part 2b (up to 868 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0054 subjects2 participants enrolled in Part 2b and subsequently re-enrolled in Part 2e.
FG0068 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Dose Extension Part 2e (up to 868 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0085 subjects
FG00910 subjects2 participants enrolled in Part 2b and 1 participant enrolled in Part 1 and subsequently re-enrolled in Part 2e.
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety population included all participants treated with at least 1 dose of any study drug. Per planned analysis, baseline characteristics data were collected and reported per study part (not per dose group).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: CGT9486 (Single-Agent)
Participants received doses of CGT9486 ranging from 250 to 1000 mg/day orally in 5 sequential dose escalation cohorts (CGT9486 250 mg QD, 350 mg QD, 500 mg QD, 1000 mg QD, and 500 mg BID). Treatment was continued until participant discontinuation, withdrawal, or study termination.
BG001
Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg
Participants received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
BG002
Part 2e: CGT9486 + Sunitinib
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally, CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally, or CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally; in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00112
BG00215
BG00351
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.0± 11.91
BG00164.4± 10.43
BG00260.1± 9.41
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Part 1: Recommended Phase 2 Dose (RP2D) of CGT9486
RP2D was determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) V4.03. DLTs: AEs that occurred during Cycle 1, possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for >7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for >7 days, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.
Safety population included all participants treated with at least 1 dose of any study drug.
Posted
Number
mg
Cycle 1 of Part 1 (Cycle length = 28 days)
ID
Title
Description
OG000
Part 1: CGT9486 (Single-Agent)
Participants received doses of CGT9486 ranging from 250 to 1000 mg/day orally in 5 sequential dose escalation cohorts (CGT9486 250 mg QD, 350 mg QD, 500 mg QD, 1000 mg QD, and 500 mg BID). Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG00024
Title
Denominators
Categories
Title
Measurements
OG0001000
Primary
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A treatment-emergent AE (TEAE) was an AE that started or worsened in severity on or after the date of the initial dose of study drug. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Safety population included all participants treated with at least 1 dose of any study drug.
Posted
Count of Participants
Participants
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days)
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Primary
Part 1: Area Under The Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24) of CGT9486
AUC0-24 was determined by the linear trapezoidal rule for the ascending portion and by the log trapezoidal rule for the descending portion of the plasma profile. For BID dosing, Cycle 1 Day 15 AUC0-24 was calculated as 2 x area under the concentration time curve from time zero to 12 hours after dosing (AUC0-12). Missing concentration data were excluded from Pharmacokinetic (PK) analysis.
PK population included all participants who had adequate PK data. Here, 'number analyzed signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms (ng)*hour/milliliter (mL)
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 1: CGT9486 500 mg QD
Primary
Part 1: Maximum Observed Plasma Concentration (Cmax) of CGT9486
Cmax was taken directly from bioanalytical data.
PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 1: CGT9486 1000 mg QD
Primary
Part 1: Time to Reach Cmax (Tmax) of CGT9486
Tmax was taken directly from merged clinical and bioanalytical data, with time presented as nominal time relative to dose.
PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.
Posted
Median
Full Range
hours
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 (Day -10 for 350 mg QD cohort) and Cycle 1 Day 15
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Primary
Part 1: Half Life (T1/2) of PLX9486
Participants in a selected Part 1 cohort (350 mg QD) participated in a PK substudy to obtain more complete information on the PK profile of PLX9486. Participants received a single dose of 350 mg of PLX9486 10 days prior to the start of repeated QD dosing and plasma concentrations were followed 0.5, 1, 2, 4, 6, and 9 hours postdose, and then once daily for 9 additional days prior to Cycle 1 Day 1.
Half life of PLX9486 can only be determined in participants who participated in the PK substudy. Sampling schedule in other Part 1 and Part 2 cohorts do not allow for determination of t1/2.
Posted
Mean
Standard Deviation
hours
Predose, 0.5, 1, 2, 4, 9, 24, 49, 72, 96, 120, 144, 168, 192, 216 hours postdose on Day -10
ID
Title
Description
OG000
Part 1: CGT9486 350 mg
Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG000
Primary
Part 2e: RP2D of CGT9486 in Combination With Sunitinib
RP2D was determined by incidence of DLT using CTCAE version 4.03 for severity grade. DLTs were defined as AEs that occurred during Cycle 1, classified as possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for >7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for >7 days or with bleeding, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for the following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.
Safety population included all participants treated with at least 1 dose of any study drug.
Posted
Number
mg
Cycle 1 of Part 2e (Cycle length = 28 days)
ID
Title
Description
OG000
Part 2e: CGT9486 + Sunitinib
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally, CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally, or CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally; in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Primary
Part 2b: RP2D of PLX9486 in Combination With Pexidartinib
RP2D was determined by incidence of DLT using CTCAE version 4.03 for severity grade. DLTs were defined as AEs that occurred during Cycle 1, classified as possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for >7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for >7 days or with bleeding, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for the following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.
Safety population included all participants treated with at least 1 dose of any study drug.
Participants in fasting condition received CGT9486 500 mg orally QD in combination with CGT9486 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2b: Number of Participants With Any TEAEs and Treatment-Related TEAEs
An AE was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A TEAE was an AE that started or worsened in severity on or after the date of the initial dose of study drug. Treatment-related TEAEs included all events reported as "possibly related" or "probably related" to any of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Safety population included all participants treated with at least 1 dose of any study drug.
Posted
Count of Participants
Participants
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 868 days)
Participants in fasting condition received CGT9486 500 mg orally QD in combination with CGT9486 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Primary
Part 2e: Number of Participants With Any TEAEs and Treatment-Related TEAEs
An AE was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A TEAE was an AE that started or worsened in severity on or after the date of the initial dose of study drug. Treatment-related TEAEs included all events reported as "possibly related" or "probably related" to any of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Safety population included all participants treated with at least 1 dose of any study drug.
Posted
Count of Participants
Participants
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 825 days)
ID
Title
Description
OG000
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Secondary
Part 1: Overall Response Rate (ORR): Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed Using RECIST V1.1
ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death.
Posted
Number
95% Confidence Interval
percentage of participants
From the date of first dose of study drug until the first appearance of CR or PR (maximum exposure: 670 days)
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 1: Progression-Free Survival (PFS), as Assessed Using RECIST V1.1
PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death.
Posted
Median
95% Confidence Interval
days
From the first date of treatment until the first documented disease progression or date of death (maximum exposure: 670 days)
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 1: Duration of Response (DOR), as Assessed Using RECIST V1.1
DOR was defined as the number of days from the date of first response (PR or CR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Here, 'Overall number of participants analyzed' signifies participants with best overall response of CR or PR.
Posted
Median
95% Confidence Interval
days
From the date of first response (PR or CR) to the date of first documented disease progression/relapse or death, whichever occurred first (maximum exposure: 670 days)
ID
Title
Description
OG000
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 2: Overall Response Rate (ORR): Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed Using RECIST V1.1
ORR was defined as the percentage of participants who achieved a best overall response of confirmed CR or PR. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.
Posted
Number
95% Confidence Interval
percentage of participants
From the date of first dose of study drug until the first appearance of CR or PR (maximum exposure: 868 days)
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG001
Secondary
Part 2: Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit, as Assessed Using RECIST V1.1
Participants were considered to experience clinical benefit if they had a best overall response of stable disease (SD) that lasted for at least 16 weeks, or confirmed best overall response of PR or CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters. CR: Disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.
Posted
Number
95% Confidence Interval
percentage of participants
From the date of first dose of study drug until the first appearance of CR, PR, or SD (maximum exposure: 868 days)
Part 2: Progression-Free Survival (PFS), as Assessed Using RECIST V1.1
PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.
Posted
Median
95% Confidence Interval
days
From the first date of treatment until the first documented disease progression or date of death (maximum exposure: 868 days)
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 2: Overall Survival
Overall Survival was defined as the number of days from the first day of treatment (Cycle 1 Day 1) until the date of death. If a participant was lost to follow-up, overall survival was censored at the date of last contact. Median was calculated using Kaplan-Meier estimate.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.
Posted
Median
95% Confidence Interval
days
From the first day of treatment until the date of death (maximum exposure: 868 days)
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 2: Overall Survival at Month 12
Percentage of participants who survived at Month 12 have been reported.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Secondary
Part 2: PFS at Month 6
PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Percentage of participants with PFS at Month 6 are reported.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.
Participants in fasting condition received CGT9486 500 mg QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Duration of Response (DOR), as Assessed Using RECIST V1.1
DOR was defined as the number of days from the date of first response (PR or CR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.
Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Here, 'Overall number of participants analyzed' signifies participants with best overall response of CR or PR.
Posted
Median
95% Confidence Interval
days
From the date of first response (PR or CR) to the date of first documented disease progression/relapse or death, whichever occurred first (maximum exposure: 868 days)
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 2: AUC0-24 of CGT9486 in Combination With Pexidartinib or Sunitinib
AUC0-24 was determined by the linear trapezoidal rule for the ascending portion and by the log trapezoidal rule for the descending portion of the plasma profile. Missing concentration data were excluded from PK analysis.
PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hour/mL
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Secondary
Part 2: Cmax of CGT9486 in Combination With Pexidartinib or Sunitinib
Cmax was taken directly from bioanalytical data.
PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Secondary
Part 2: Tmax of CGT9486 in Combination With Pexidartinib or Sunitinib
Tmax was taken directly from merged clinical and bioanalytical data, with time presented as nominal time relative to dose.
PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.
Posted
Median
Full Range
hours
Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Time Frame
From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e)
Description
Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
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
Part 1: CGT9486 250 mg QD
Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
1
3
0
3
3
3
EG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
3
4
2
4
4
4
EG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
3
3
1
3
3
3
EG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
5
7
1
7
7
7
EG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
0
8
0
8
8
8
EG007
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
1
3
1
3
3
3
EG008
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
1
5
1
5
5
5
EG009
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
4
10
4
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG0030 affected7 at risk
EG0040 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Prophylaxis against dehydration
Surgical and medical procedures
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Post procedural hypotension
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG0032 affected7 at risk
EG0044 affected7 at risk
EG0051 affected4 at risk
EG0063 affected8 at risk
EG0073 affected3 at risk
EG0082 affected5 at risk
EG0098 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0022 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Salivary gland pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected4 at risk
EG0022 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0022 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Platelet count increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
White blood cell count increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Body temperature increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected4 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Swelling face
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Early satiety
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hair disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Yellow skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin odour abnormal
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Eye infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Eyelash discolouration
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pulmonary valve incompetence
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Bartholin's cyst
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
This is a gender specific AE that affects only female participants.
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
This is a gender specific AE that affects only male participants.
EG0000 affected0 at risk
EG0010 affected3 at risk
EG0020 affected0 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
This is a gender specific AE that affects only female participants.
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0037
OG0047
Title
Denominators
Categories
Title
Measurements
OG0003
OG0014
OG0023
OG0037
OG0047
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0037
OG0047
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG0047
Title
Measurements
OG0009240± 8.7
OG0017200± 20.7
OG0025980± 41.7
OG003
Cycle 1, Day 15
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0037
OG0047
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG0047
Title
Measurements
OG000499± 6.92
OG001332± 17.9
OG002382± 6.48
OG003
Cycle 1, Day 15
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0037
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1:CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0037
OG0047
Title
Denominators
Categories
Cycle 1, Day 1 (or Day -10)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG0047
Title
Measurements
OG0009(9 to 24)
OG00116.5(9 to 24)
OG00215(6 to 24)
OG003
Cycle 1, Day 15
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0036
4
Title
Denominators
Categories
Title
Measurements
OG00075.4± 26.1
Units
Counts
Participants
OG00018
Title
Denominators
Categories
Title
Measurements
OG0001000
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG000NANA signifies RP2D was not estimable due to no DLTs were experienced during Part 2b.
OG001NANA signifies RP2D was not estimable due to no DLTs were experienced during Part 2b.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0004
OG0018
Related TEAEs
Title
Measurements
OG0004
OG0017
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0015
OG00210
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0003
OG0015
OG00210
Related TEAEs
Title
Measurements
OG0003
OG0015
OG0029
OG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0037
OG0046
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 70.8)
OG0010(0.0 to 60.2)
OG0020(0.0 to 70.8)
OG00314.3(0.4 to 57.9)
OG0040(0.0 to 45.9)
OG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG0037
OG0046
Title
Denominators
Categories
Title
Measurements
OG00054(28 to 56)
OG00153(20 to 53)
OG00248(47 to 221)
OG003144(38 to 335)
OG004186(20 to 669)
OG001
Part 1: CGT9486 350 mg QD
Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 1: CGT9486 500 mg QD
Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 1: CGT9486 1000 mg QD
Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 1: CGT9486 500 mg BID
Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0018
OG0023
OG0035
OG0047
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.8 to 90.6)
OG0010(0.0 to 36.9)
OG00233.3(0.8 to 90.6)
OG0030(0.0 to 52.2)
OG00428.6(3.7 to 71.0)
Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0018
OG0023
OG0035
OG0047
Title
Denominators
Categories
Title
Measurements
OG000333(234 to 336)
OG001128(26 to 867)
OG002NA(503 to NA)Due to smaller number of participants with an event, Median and upper limit of 95% confidence interval (CI) could not be calculated.
OG003319(26 to 530)
OG004NA(41 to NA)Due to smaller number of participants with an event, Median and upper limit of 95% CI could not be calculated.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e:CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0018
OG0023
OG0035
OG0047
Title
Denominators
Categories
Title
Measurements
OG000853(240 to 853)
OG001414(106 to NA)Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.
OG002NA(551 to NA)Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.
OG003362(164 to NA)Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.
OG004NA(98 to NA)Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0003
OG0018
OG0023
OG0035
OG0047
Title
Denominators
Categories
Title
Measurements
OG00066.7(5.4 to 94.5)
OG00155.6(7.3 to 87.6)
OG002100(100 to 100)
OG00340.0(5.2 to 75.3)
OG00468.6(21.3 to 91.2)
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0030
OG0042
Title
Denominators
Categories
Title
Measurements
OG000169
OG002NA(NA to NA)Due to smaller number of participants with an event, data could not be calculated.
OG004NA(NA to NA)Due to smaller number of participants with an event, data could not be calculated.
OG002
Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0004
OG0018
OG0023
OG0035
OG00410
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0004
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
Title
Measurements
OG0007810± 31.6
OG0017910± 21.9
OG0029800± 69.4
OG003
Cycle 1, Day 15
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0035
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0004
OG0018
OG0023
OG0035
OG00410
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0004
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
Title
Measurements
OG000384± 34.4
OG001412± 26.8
OG002512± 69.2
OG003
Cycle 1, Day 15
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0035
Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG003
Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
OG004
Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg
Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Units
Counts
Participants
OG0004
OG0018
OG0023
OG0035
OG00410
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0004
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
Title
Measurements
OG0008(3 to 24)
OG0019(5 to 24)
OG0029(7 to 9)
OG003
Cycle 2, Day 15
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0035
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
3 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0063 affected8 at risk
EG0073 affected3 at risk
EG0082 affected5 at risk
EG0095 affected10 at risk
1 affected
7 at risk
EG0042 affected7 at risk
EG0051 affected4 at risk
EG0061 affected8 at risk
EG0072 affected3 at risk
EG0082 affected5 at risk
EG0094 affected10 at risk
1 affected
7 at risk
EG0041 affected7 at risk
EG0051 affected4 at risk
EG0061 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0093 affected10 at risk
0 affected
7 at risk
EG0042 affected7 at risk
EG0051 affected4 at risk
EG0061 affected8 at risk
EG0072 affected3 at risk
EG0083 affected5 at risk
EG0090 affected10 at risk
1 affected
7 at risk
EG0043 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0072 affected3 at risk
EG0081 affected5 at risk
EG0092 affected10 at risk
2 affected
7 at risk
EG0041 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0072 affected3 at risk
EG0080 affected5 at risk
EG0092 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0051 affected4 at risk
EG0061 affected8 at risk
EG0071 affected3 at risk
EG0081 affected5 at risk
EG0093 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0071 affected3 at risk
EG0081 affected5 at risk
EG0091 affected10 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0082 affected5 at risk
EG0090 affected10 at risk
2 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
3 affected
7 at risk
EG0044 affected7 at risk
EG0051 affected4 at risk
EG0064 affected8 at risk
EG0072 affected3 at risk
EG0081 affected5 at risk
EG0097 affected10 at risk
3 affected
7 at risk
EG0043 affected7 at risk
EG0051 affected4 at risk
EG0062 affected8 at risk
EG0072 affected3 at risk
EG0081 affected5 at risk
EG0095 affected10 at risk
2 affected
7 at risk
EG0043 affected7 at risk
EG0051 affected4 at risk
EG0061 affected8 at risk
EG0071 affected3 at risk
EG0081 affected5 at risk
EG0095 affected10 at risk
0 affected
7 at risk
EG0043 affected7 at risk
EG0051 affected4 at risk
EG0063 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0092 affected10 at risk
4 affected
7 at risk
EG0042 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0042 affected7 at risk
EG0051 affected4 at risk
EG0062 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0092 affected10 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0051 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0094 affected10 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0094 affected10 at risk
1 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
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EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
1 affected
7 at risk
EG0041 affected7 at risk
EG0051 affected4 at risk
EG0062 affected8 at risk
EG0071 affected3 at risk
EG0082 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0072 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
2 affected
7 at risk
EG0041 affected7 at risk
EG0053 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0083 affected5 at risk
EG0094 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0093 affected10 at risk
0 affected
7 at risk
EG0042 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0072 affected3 at risk
EG0081 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0092 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0051 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
2 at risk
EG0040 affected0 at risk
EG0050 affected1 at risk
EG0061 affected2 at risk
EG0070 affected3 at risk
EG0080 affected2 at risk
EG0090 affected4 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
5 at risk
EG0040 affected7 at risk
EG0050 affected3 at risk
EG0061 affected6 at risk
EG0070 affected0 at risk
EG0080 affected3 at risk
EG0090 affected6 at risk
0 affected
2 at risk
EG0040 affected0 at risk
EG0050 affected1 at risk
EG0060 affected2 at risk
EG0070 affected3 at risk
EG0080 affected2 at risk
EG0091 affected4 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0060 affected8 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected10 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected4 at risk
EG0061 affected8 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected10 at risk
11000
± 26.3
OG004NA± NAAUC(0-24) on Cycle 1 Day 1 cannot be determined from the 500 mg BID group due to BID dosing (2nd dose given 12 hours after the 1st dose) and limitation of sampling schedule (sampling up to 9 hours after the 1st dose and no samples collected after the 2nd dose).