122
Participants
Start Date
July 11, 2011
Primary Completion Date
October 16, 2020
Study Completion Date
October 16, 2020
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.
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.
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.
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.
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.
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.
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.
Virginia Oncology Associates, Norfolk
Florida Cancer Specialists - Sarasota, Sarasota
SCRI, Nashville
Hospital Clinico Universitario de Valencia, Valencia
University Of Michigan, Ann Arbor
Comprehensive Cancer Centers of Nevada, Las Vegas
California Pacific Med Center, San Francisco
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif
Massachusetts General Hospital, Boston
Hospital Universitari Vall d'Hebron, Barcelona
The Royal Marsden Hospital, Sutton
Lead Sponsor
Genentech, Inc.
INDUSTRY