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

• Status: Completed
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Key Inclusion 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 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

• 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.