Trials / Completed
CompletedNCT02545504
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 432 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Andecaliximab | 800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle |
| DRUG | Placebo | Administered intravenously on Days 1 and 15 of each treatment cycle |
| DRUG | Leucovorin | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| DRUG | 5-fluorouracil | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
| DRUG | Oxaliplatin | Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle |
Timeline
- Start date
- 2015-10-13
- Primary completion
- 2019-05-15
- Completion
- 2019-05-15
- First posted
- 2015-09-10
- Last updated
- 2020-05-26
- Results posted
- 2020-04-28
Locations
134 sites across 16 countries: United States, Australia, Belgium, Chile, Colombia, Czechia, France, Germany, Hungary, Italy, Peru, Poland, Romania, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02545504. Inclusion in this directory is not an endorsement.