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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 432
- Locations
- 134
- Primary Endpoint
- Overall Survival (OS)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Intervention: Andecaliximab (Drug)
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Intervention: Leucovorin (Drug)
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Intervention: 5-fluorouracil (Drug)
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Intervention: Oxaliplatin (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Intervention: Placebo (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Intervention: Leucovorin (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Intervention: 5-fluorouracil (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Intervention: Oxaliplatin (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Andecaliximab + mFOLFOX6 median follow-up at the time of final analysis: 19.43 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 19.45 months
OS was defined as the time interval from the date of randomization to death from any cause.
Secondary Outcomes
- Progression-free Survival (PFS)(Andecaliximab + mFOLFOX6 median follow-up at the time of the final analysis: 18.64 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 18.74 months)
- Objective Response Rate (ORR)(Up to 135.4 weeks at the time of final analysis)
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days)
- Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities(First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days)