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

PHASE1CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

July 11, 2011

Primary Completion Date

October 16, 2020

Study Completion Date

October 16, 2020

Conditions
Neoplasms
Interventions
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.

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.

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.

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.

Trial Locations (11)

23502

Virginia Oncology Associates, Norfolk

34232

Florida Cancer Specialists - Sarasota, Sarasota

37203

SCRI, Nashville

46010

Hospital Clinico Universitario de Valencia, Valencia

48109

University Of Michigan, Ann Arbor

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

94115

California Pacific Med Center, San Francisco

94805

Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif

02114

Massachusetts General Hospital, Boston

08035

Hospital Universitari Vall d'Hebron, Barcelona

SM2 5PT

The Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY