Clinical Trials /

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

NCT02545504

Description:

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

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">GS-5745</span> With <span class="go-doc-concept go-doc-intervention">mFOLFOX6</span> as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Title

  • Brief Title: GS-5745 With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
  • Official 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
  • Clinical Trial IDs

    NCT ID: NCT02545504

    ORG ID: GS-US-296-1080

    NCI ID: 2015-001526-42

    Trial Conditions

    Gastric Adenocarcinoma

    Trial Interventions

    Drug Synonyms Arms
    GS-5745 GS-5745
    GS-5745 Placebo Placebo
    Leucovorin GS-5745, Placebo
    5-fluorouracil GS-5745, Placebo
    Oxaliplatin GS-5745, Placebo

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    GS-5745 Experimental GS-5745 plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by GS-5745 plus LV+5-FU during subsequent cycles GS-5745, Leucovorin, 5-fluorouracil, Oxaliplatin
    Placebo Active Comparator Placebo to match GS-5745 plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo to match GS-5745 plus LV+5-FU during subsequent cycles GS-5745 Placebo, Leucovorin, 5-fluorouracil, Oxaliplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Adults with adenocarcinoma of the stomach or gastroesophageal junction

    - Adequate blood, liver, and kidney function

    Exclusion Criteria:

    - Previous chemotherapy for locally advanced or metastatic gastric cancer.

    - Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer

    - HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Progression-free survival

    Objective response rate

    Trial Keywords

    Gastroesophageal junction (GEJ)

    Stomach cancer