Clinical Trials /

Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors

NCT01362374

Description:

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of ipatasertib administered in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1, approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be evaluated to determine the maximum tolerated dose (MTD) of ipatasertib in a given combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to further characterize the safety and tolerability of ipatasertib in these combinations and to confirm a potential recommended Phase II dose of ipatasertib for each regimen. NOTE: Arms A, B, and C are closed.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Prostate Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
  • Official Title: A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: PAM4983g
  • SECONDARY ID: GO27845
  • SECONDARY ID: 2011-000782-13
  • NCT ID: NCT01362374

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
5-FUAdrucilArm B (GDC-0068 + mFOLFOX6)
DocetaxelArm A (GDC-0068 + Docetaxel)
EnzalutamideArm D (GDC-0068 + Enzalutamide)
GDC-0068Arm A (GDC-0068 + Docetaxel)
LeucovorinWellcovorinArm B (GDC-0068 + mFOLFOX6)
OxaliplatinEloxatinArm B (GDC-0068 + mFOLFOX6)
PaclitaxelTaxolArm C (GDC-0068 + Paclitaxel)

Purpose

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0068 administered in combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of GDC-0068 administered in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1, approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be evaluated to determine the maximum tolerated dose (MTD) of GDC-0068 in a given combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to further characterize the safety and tolerability of GDC-0068 in these combinations and to confirm a potential recommended Phase II dose of GDC-0068 for each regimen.

Trial Arms

NameTypeDescriptionInterventions
Arm A (GDC-0068 + Docetaxel)ExperimentalParticipants will receive GDC-0068 at a starting dose of 100 milligrams (mg) once daily for 14 consecutive days (beginning on Day 2) in combination with docetaxel on Day 1, in 21-day continuous cycles, until disease progression, unacceptable toxicity, or use of another anti-cancer therapy, whichever occurs first.
  • Docetaxel
  • GDC-0068
Arm B (GDC-0068 + mFOLFOX6)ExperimentalParticipants will receive GDC-0068 at a starting dose of 100 mg once daily for 7 consecutive days (beginning on Day 1) in combination with mFOLFOX6 chemotherapy (comprising of oxaliplatin, leucovorin, and 5-FU) on Day 1, in 14-day continuous cycles, until disease progression, unacceptable toxicity, or use of another anti-cancer therapy, whichever occurs first.
  • 5-FU
  • GDC-0068
  • Leucovorin
  • Oxaliplatin
Arm C (GDC-0068 + Paclitaxel)ExperimentalParticipants will receive GDC-0068 at a dose of 600 mg once daily for 21 consecutive days (beginning on Day 1) in combination with paclitaxel on Days 1, 8, and 15, in 28-day continuous cycles, until disease progression, unacceptable toxicity, or use of another anti-cancer therapy, whichever occurs first.
  • GDC-0068
  • Paclitaxel
Arm D (GDC-0068 + Enzalutamide)ExperimentalParticipants will receive GDC-0068 at a dose of 400 mg once daily alone for 8 days, then from Day 9, GDC-0068 will be administered in combination with enzalutamide once daily for 27 days (Cycle 1 duration = 35 days). Participants will receive both GDC-0068 and enzalutamide once daily continuously in subsequent 28-days cycles, until disease progression, unacceptable toxicity, or use of another anti-cancer therapy, whichever occurs first. Higher (up to 600 mg) or lower dose of GDC-0068 may be evaluated in subsequent cycles depending upon safety, tolerability, and pharmacokinetics of the first cycle.
  • Enzalutamide
  • GDC-0068

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening

          -  Histologically or cytologically documented advanced or metastatic solid tumors for
             which established therapy either does not exist or has proven ineffective or
             intolerable

          -  Life expectancy greater than or equal to (>=) 12 weeks

          -  Adequate hematologic and end organ function

          -  For female participants of childbearing potential and male participants with partners
             of childbearing potential, agreement (by participant and/or partner) to use highly
             effective forms of contraception and to continue its use for the duration of the study
             and for 4 months after last dose of study treatment (for females) and 6 months after
             last dose of study treatment (for males)

        Exclusion Criteria:

          -  Prior anti-cancer therapy that fulfills the following criteria: a total of more than
             three (Arms A and B) or two (Arms C and D) prior cytotoxic chemotherapy regimens,
             high-dose chemotherapy requiring stem-cell support, and irradiation to >=25 percent
             (%) of bone marrow-bearing areas

          -  Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy,
             oral contraceptives, or gonadotropin-releasing hormone (GnRH) agonists or antagonists
             for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except
             palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4
             weeks prior to initiation of GDC-0068. Exceptions are kinase inhibitors approved by
             local regulatory authorities, which may be used within 2 weeks prior to initiation of
             GDC-0068, provided that any clinically-relevant drug-related toxicity has completely
             resolved and prior approval is obtained from the Medical Monitor

          -  Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0068

          -  History of Type 1 or Type 2 diabetes requiring regular medication

          -  Grade >= 2 heart failure or history of unstable angina

          -  History of clinically significant ventricular arrhythmias or active ventricular
             arrhythmia requiring medication

          -  For Arm D only: History of seizure, unexplained loss of consciousness, transient
             ischemic attack within 12 months of enrollment, cerebral vascular accident, and any
             brain metastases
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With Dose Limiting Toxicities (DLTs)
Time Frame:Arm A: Days 2-21 of Cycle 1 (cycle length=21 days); Arm B: Days 1-14 of Cycles 1 and 2 (cycle length=14 days); Arm C: Days 1-28 of Cycle 1 (cycle length=28 days); Arm D: Days 1-35 of Cycle 1 (cycle length=28 days except for Cycle 1=35 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Arm A: Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Docetaxel
Time Frame:Arm A: immediately prior to docetaxel infusion, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours (hrs) after start of docetaxel infusion on Day 1 Cycles 1 and 2 (1 cycle=21 days)
Safety Issue:
Description:
Measure:Arm A: Plasma Terminal Half-Life (t1/2) of Docetaxel
Time Frame:Arm A: immediately prior to docetaxel infusion, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours (hrs) after start of docetaxel infusion on Day 1 Cycles 1 and 2 (1 cycle=21 days)
Safety Issue:
Description:
Measure:Arm A: Plasma Clearance (CL) of Docetaxel
Time Frame:Arm A: immediately prior to docetaxel infusion, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours (hrs) after start of docetaxel infusion on Day 1 Cycles 1 and 2 (1 cycle=21 days)
Safety Issue:
Description:
Measure:Arm A: Volume of Distribution (Vz) of Docetaxel
Time Frame:Arm A: immediately prior to docetaxel infusion, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours (hrs) after start of docetaxel infusion on Day 1 Cycles 1 and 2 (1 cycle=21 days)
Safety Issue:
Description:
Measure:Arm B: AUC(0-inf) of Total Platinum
Time Frame:Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Plasma t1/2 of Total Platinum
Time Frame:Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Plasma CL of Total Platinum
Time Frame:Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Vz of Total Platinum
Time Frame:Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Maximum Observed Plasma Concentration (Cmax) of Total Platinum
Time Frame:Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Cmax of 5-FU
Time Frame:Arm B: 2, 2.25, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Steady-State Concentration (Css) of 5-FU
Time Frame:Arm B: 2, 2.25, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm B: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of 5-FU
Time Frame:Arm B: 2, 2.25, 3, 4, 6, 24, 48 hrs after GDC-0068 Day 1 dose in Cycle 1 (1 cycle=14 days)
Safety Issue:
Description:
Measure:Arm C: Cmax of Paclitaxel
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Cmax of Paclitaxel Metabolite
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: AUC(0-inf) of Paclitaxel
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: AUC(0-inf) of Paclitaxel Metabolite
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Plasma CL of Paclitaxel
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Plasma CL of Paclitaxel Metabolite
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Vz of Paclitaxel
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Vz of Paclitaxel Metabolite
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Plasma t1/2 of Paclitaxel
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm C: Plasma t1/2 of Paclitaxel Metabolite
Time Frame:Arm C: 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day 8 dose in Cycle 1 (1 cycle=28 days)
Safety Issue:
Description:
Measure:Arm D: AUC(0-24) of Enzalutamide
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 Day (D) 8 dose in Cycle (C) 2, D1C3 (Stage [S] 2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: AUC(0-24) of Enzalutamide Metabolite
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Time to Reach Cmax (Tmax) of Enzalutamide
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Tmax of Enzalutamide Metabolite
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Cmax at Steady State (Cmax,ss) of Enzalutamide
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Cmax,ss of Enzalutamide Metabolite
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: AUC(0-24) of GDC-0068
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C1, D8C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: AUC(0-24) of GDC-0068 Metabolite (G037720)
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C1, D8C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Tmax of GDC-0068
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C1, D8C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Tmax of GDC-0068 Metabolite
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C1, D8C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Cmax,ss of GDC-0068
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C1, D8C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Arm D: Cmax,ss of GDC-0068 Metabolite
Time Frame:Arm D: immediately prior to GDC-0068 dose, 1, 2, 3, 4, 6, 24 hrs after GDC-0068 D8 dose in C1, D8C2, D1C3 (S2) (1 cycle=28 days, Cycle 1=35 days)
Safety Issue:
Description:
Measure:Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of GDC-0068
Time Frame:Arm A: pre-dose (PRDS), 0.5,1,2,3,4,6,24 hrs post-dose (PSDS) on D2C1; Arm B: PRDS, 0.5,1,2,3,4,6,24 hrs PSDS D1C1; Arm C: PRDS, 1,2,3,4,6,24 hrs PSDS D8C1; Arm D: PRDS, 1,2,3,4,6,24 hrs PSDS D8C1, D8C2, D1C3 (S2)
Safety Issue:
Description:
Measure:AUC(0-last) of GDC-0068 Metabolite
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2)
Safety Issue:
Description:
Measure:Tmax of GDC-0068
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2)
Safety Issue:
Description:
Measure:Tmax of GDC-0068 Metabolite
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2)
Safety Issue:
Description:
Measure:Cmax of GDC-0068
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2)
Safety Issue:
Description:
Measure:Cmax of GDC-0068 Metabolite
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2)
Safety Issue:
Description:
Measure:Cmin of GDC-0068
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2) and PRDS, 2, 4 hrs PSDS D1C3 (S1)
Safety Issue:
Description:
Measure:Cmin of GDC-0068 Metabolite
Time Frame:Arm A: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS on D2C1; Arm B: PRDS, 0.5, 1, 2, 3, 4, 6, 24 hrs PSDS D1C1; Arm C: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1; Arm D: PRDS, 1, 2, 3, 4, 6, 24 hrs PSDS D8C1, D8C2, D1C3 (S2) and PRDS, 2, 4 hrs PSDS D1C3 (S1)
Safety Issue:
Description:
Measure:Percentage of Participants With Objective Response as Determined by Investigator Review of Tumor Assessments Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame:Baseline up to disease progression or death, whichever occurs first (up to approximately 6 years)
Safety Issue:
Description:
Measure:Duration of Response (DOR) as Determined by Investigator Review of Tumor Assessments Using RECIST v1.1
Time Frame:Baseline up to disease progression or death, whichever occurs first (up to approximately 6 years)
Safety Issue:
Description:
Measure:Progression-free Survival (PFS) as Determined by Investigator Review of Tumor Assessments Using RECIST v1.1
Time Frame:Baseline up to disease progression or death, whichever occurs first (up to approximately 6 years)
Safety Issue:
Description:
Measure:Arm D: Radiographic Progression-free Survival (rPFS) as Determined by Investigator
Time Frame:Arm D: Baseline up to radiographic disease progression or death, whichever occurs first (up to approximately 6 years)
Safety Issue:
Description:
Measure:Time to Treatment Failure (TTF)
Time Frame:Baseline up to treatment discontinuation for any reason (up to approximately 6 years)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

November 21, 2017