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3G-15-4: 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

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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that is inoperable, locally advanced or metastatic and not amenable to curative therapy
  • Adequate hematologic, liver, coagulation and kidney function
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Key

  • 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
  • Pregnant or breast feeding women
  • Individuals with known or suspected central nervous system metastases or individuals requiring chronic daily treatment with oral corticosteroids
  • Grade ≥ 2 peripheral neuropathy Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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