GS-US-296-1080, A Study to evaluate the efficacy&safety of GS-5745
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
IRAS ID
193988
Contact name
David Cunningham
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2015-001526-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
The purpose of this study is to compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by overall survival (OS), in subjects who are ≥18 years old with histologically confirmed, inoperable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ) and who have received no prior treatment for advanced or metastatic gastric cancer.
In this study, there will be approximately 430 patients. The study will take place at about 175 centres in Latin America and other participating countries. This study will last approximately 5 years.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0334
Date of REC Opinion
4 Apr 2016
REC opinion
Further Information Favourable Opinion