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Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT02545504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2020-05-26

Study results available
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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

  • Gastric Adenocarcinoma

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2019-05-15
Completion
2019-05-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Peru
  • Poland
  • Romania
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545504 on ClinicalTrials.gov