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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 134
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
干预措施: Andecaliximab (Drug)
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
干预措施: Leucovorin (Drug)
Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
干预措施: 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
干预措施: Oxaliplatin (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
干预措施: Placebo (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
干预措施: Leucovorin (Drug)
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
干预措施: 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
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 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.
次要结局
- 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)