A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

• Status: Completed
• Trial end date: 2021-01-26

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs (up to approximately 2 years).

• Phase: Phase 2

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin