Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (GAMMA-1)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Gastric Adenocarcinoma

Treatments: Drug: 5-fluorouracil; Drug: Andecaliximab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545504

2015-001526-42 (EudraCT Number)

GS-US-296-1080

Details and patient eligibility

About

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.

Enrollment: 432 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 2 patient groups, including a placebo group

Andecaliximab

Experimental group

Description:

Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles

Treatment:

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Andecaliximab

Drug: 5-fluorouracil

Placebo

Placebo Comparator group

Description:

Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles

Treatment:

Drug: Leucovorin

Drug: Placebo

Drug: Oxaliplatin

Drug: 5-fluorouracil