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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID: NCT01362374
Run by: Genentech, Inc.
People needed: 122
Starts: 2011-07-11
Expected to finish: 2020-10-16
Last updated by the study team: 2022-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

California Pacific Med Center — San Francisco, California, United States
Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University Of Michigan — Ann Arbor, Michigan, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
SCRI — Nashville, Tennessee, United States
Virginia Oncology Associates — Norfolk, Virginia, United States
Institut Gustave Roussy; Departement Oncologie Medicale — Villejuif, France
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital Clinico Universitario de Valencia — Valencia, Spain
The Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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