Spots Global Cancer Trial Database for Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
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Trial Identification
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 Ipatasertib (GDC-0068) in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors
Study ID: NCT01362374
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Daniel Maslyar, M.D.
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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