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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362374
Recruitment Status : Active, not recruiting
First Posted : May 30, 2011
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE May 26, 2011
First Posted Date  ICMJE May 30, 2011
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE July 11, 2011
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • 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) ]
  • Maximum Tolerated Dose (MTD) of Ipatasertib [ 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) ]
  • Recommended Phase II Dose of Ipatasertib [ 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) ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 6 years) ]
  • Percentage of Participants With AEs by Severity as Graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) [ Time Frame: Baseline up to 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 6 years) ]
  • Number of Cycles of Treatment Received for Each Intervention [ Time Frame: Baseline up to 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 6 years) ]
  • Mean Dose Administered for Each Intervention During Study [ Time Frame: Baseline up to 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 6 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Days 2-21 of Cycle 1 for Arm A; and Days 1-14 of Cycles 1 and 2 for Arm B ]
  • Nature of dose limiting toxicities (DLTs) [ Time Frame: Days 2-21 of Cycle 1 for Arm A; and Days 1-14 of Cycles 1 and 2 for Arm B ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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 ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • 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 ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • Arm B: Plasma CL of Total Platinum [ Time Frame: Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • Arm B: Vz of Total Platinum [ Time Frame: Arm B: 1, 2, 2.25, 2.5, 3, 4, 6, 24, 48 hrs after ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • 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 ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • Arm B: Cmax of 5-FU [ Time Frame: Arm B: 2, 2.25, 3, 4, 6, 24, 48 hrs after ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • Arm B: Steady-State Concentration (Css) of 5-FU [ Time Frame: Arm B: 2, 2.25, 3, 4, 6, 24, 48 hrs after ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • 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 ipatasertib Day 1 dose in Cycle 1 (1 cycle=14 days) ]
  • Arm C: Cmax of Paclitaxel [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Cmax of Paclitaxel Metabolite [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: AUC(0-inf) of Paclitaxel [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: AUC(0-inf) of Paclitaxel Metabolite [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Plasma CL of Paclitaxel [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Plasma CL of Paclitaxel Metabolite [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Vz of Paclitaxel [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Vz of Paclitaxel Metabolite [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Plasma t1/2 of Paclitaxel [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm C: Plasma t1/2 of Paclitaxel Metabolite [ Time Frame: Arm C: 1, 2, 3, 4, 6, 24 hrs after ipatasertib Day 8 dose in Cycle 1 (1 cycle=28 days) ]
  • Arm D: AUC(0-24) of Enzalutamide [ Time Frame: Day (D) 8 Cycle (C) 1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: AUC(0-24) of Enzalutamide Metabolite [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Time to Reach Cmax (Tmax) of Enzalutamide [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Tmax of Enzalutamide Metabolite [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Cmax at Steady State (Cmax,ss) of Enzalutamide [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Cmax,ss of Enzalutamide Metabolite [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: AUC(0-24) of Ipatasertib [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: AUC(0-24) of Ipatasertib Metabolite (G037720) [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Tmax of Ipatasertib [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Tmax of Ipatasertib Metabolite [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Cmax,ss of Ipatasertib [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Arm D: Cmax,ss of Ipatasertib Metabolite [ Time Frame: D8 C1,2 and D1 C3: Immediately prior to ipatasertib dose, 1,2,3,4,6,24 hours post dose (C=28 days, C1=35 days) ]
  • Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Ipatasertib [ 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) ]
  • AUC(0-last) of Ipatasertib 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) ]
  • Tmax of Ipatasertib [ 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) ]
  • Tmax of Ipatasertib 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) ]
  • Cmax of Ipatasertib [ 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) ]
  • Cmax of Ipatasertib 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) ]
  • Cmin of Ipatasertib [ 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) ]
  • Cmin of Ipatasertib 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Time to Treatment Failure (TTF) [ Time Frame: Baseline up to treatment discontinuation for any reason (up to approximately 6 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
  • Incidence of adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ]
  • Nature adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ]
  • Severity of adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology of Ipatasertib (GDC-0068) in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: 5-FU
    5-FU at a dose level of 400 mg/m^2 as intravenous (IV) injection followed by a dose of 2400 mg/m^2 as IV infusion over 46 hrs will be administered on Day 1 of each 14-day cycle until disease progression or unacceptable toxicity.
    Other Name: Adrucil
  • Drug: Docetaxel
    Docetaxel will be administered at dose level of 75 mg/m^2 as IV infusion over 1 hr on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
  • Drug: Enzalutamide
    Enzalutamide will be administered orally at a dose level of 160 mg once daily continuously as per schedule defined in respective arm until disease progression or unacceptable toxicity.
  • Drug: Ipatasertib
    Ipatasertib will be administered orally (in escalating doses during Stage 1 followed by at a dose decided during Stage 1) as per schedule defined in the respective arms.
  • Drug: Leucovorin
    Leucovorin at a dose level of 400 mg/m^2 as IV infusion over 2 hrs will be administered on Day 1 of each 14-day cycle until disease progression or unacceptable toxicity.
    Other Name: Wellcovorin
  • Drug: Oxaliplatin
    Oxaliplatin at a dose level of 85 mg/m^2 as IV infusion over 2 hours will be administered on Day 1 of each 14-day cycle until disease progression or unacceptable toxicity.
    Other Name: Eloxatin
  • Drug: Paclitaxel
    Paclitaxel at a dose of 90 mg/m^2 as IV infusion over 1 hr will be administered on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
    Other Name: Taxol
Study Arms  ICMJE
  • Experimental: Arm A (Ipatasertib + Docetaxel)
    Participants will receive ipatasertib 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.
    Interventions:
    • Drug: Docetaxel
    • Drug: Ipatasertib
  • Experimental: Arm B (Ipatasertib + mFOLFOX6)
    Participants will receive ipatasertib 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.
    Interventions:
    • Drug: 5-FU
    • Drug: Ipatasertib
    • Drug: Leucovorin
    • Drug: Oxaliplatin
  • Experimental: Arm C (Ipatasertib + Paclitaxel)
    Participants will receive ipatasertib 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.
    Interventions:
    • Drug: Ipatasertib
    • Drug: Paclitaxel
  • Experimental: Arm D (Ipatasertib + Enzalutamide)
    Participants will receive ipatasertib at a dose of 400 mg once daily alone for 8 days, then from Day 9, ipatasertib will be administered in combination with enzalutamide once daily for 27 days (Cycle 1 duration = 35 days). Participants will receive both ipatasertib 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 ipatasertib may be evaluated in subsequent cycles depending upon safety, tolerability, and pharmacokinetics of the first cycle.
    Interventions:
    • Drug: Enzalutamide
    • Drug: Ipatasertib
Publications * Isakoff SJ, Tabernero J, Molife LR, Soria JC, Cervantes A, Vogelzang NJ, Patel MR, Hussain M, Baron A, Argilés G, Conkling PR, Sampath D, Maslyar D, Patel P, Chan W, Gendreau S, Musib L, Xu N, Ma H, Lin K, Bendell J. Antitumor activity of ipatasertib combined with chemotherapy: results from a phase Ib study in solid tumors. Ann Oncol. 2020 May;31(5):626-633. doi: 10.1016/j.annonc.2020.02.007. Epub 2020 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 1, 2016)
123
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
96
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ipatasertib. Exceptions are kinase inhibitors approved by local regulatory authorities, which may be used within 2 weeks prior to initiation of ipatasertib, 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 ipatasertib
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362374
Other Study ID Numbers  ICMJE PAM4983g
GO27845 ( Other Identifier: Hoffmann-La Roche )
2011-000782-13 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Maslyar, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP