CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 432 enrolled
Drug / intervention
Andecaliximab +4 moredrug
Likely dose
Andecaliximab 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02545504
NCT02545504Phase 3Completed

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

Gilead Sciences·interventional·Posted Sep 10, 2015·Updated May 26, 2020

In Brief

A Phase 3 clinical trial evaluating Andecaliximab, Placebo, and 3 other interventions for Gastric Adenocarcinoma. Completed, enrolled 432 participants across 134 sites in 16 countries.

Detailed Summary

The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Chile, Colombia, Czechia, France, Germany, Hungary, Italy, Peru, Poland, Romania, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 10, 2015
Enrollment StartOct 13, 2015
Primary CompletionMay 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.8 years ago

Interventions

Andecaliximabdrug

800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle

Placebodrug

Administered intravenously on Days 1 and 15 of each treatment cycle

Leucovorindrug

Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle

5-fluorouracildrug

Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle

Oxaliplatindrug

Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle