A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 67
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI
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
- •Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
- •Mutant-type KRAS tumor at screening
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
- •Adequate hematology, renal, hepatic, and coagulation function
排除标准
- •History or known presence of central nervous system metastases
- •History of other malignancy
- •Prior irinotecan-based chemotherapy for advanced/metastatic disease
- •Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
- •Uncontrolled cardiovascular disease
研究组 & 干预措施
Arm A
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
干预措施: FOLFIRI (Other)
Arm A
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
干预措施: Placebo (Other)
Arm C
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
干预措施: FOLFIRI (Other)
Arm C
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
干预措施: Placebo (Other)
Arm B
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
干预措施: FOLFIRI (Other)
Arm B
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
干预措施: Placebo (Other)
Arm B
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
干预措施: AMG 479 (Biological)
Arm A
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
干预措施: AMG 655 (Biological)
结局指标
主要结局
Progression Free Survival
时间窗: Length of Study
次要结局
- Overall Survival, Objective Response, Duration of Response, Time to Response(Length of Study)
- Significant laboratory abnormalities(Length of Study)
- Incidence of antibody formation(Length of Study)
- Incidence of adverse events(Length of Study)