A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
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
- Triple (Participant, Care Provider, 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 or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- •Subjects with measurable or unmeasurable disease
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •Men or women at least 18 years of age
- •Adequate hematologic, renal, hepatic and coagulation function
排除标准
- •History or known presence of central nervous system (CNS) metastases
- •Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
- •Any investigational agent or therapy for advanced or metastatic CRC
- •Clinically significant cardiac disease
- •Clinically significant peripheral neuropathy
- •Active inflammatory bowel disease
- •Recent gastrointestinal ulcer or hemorrhage
- •Recent arterial thrombotic event or pulmonary embolus
- •Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
- •Recent major surgical procedure or not yet recovered from major surgery
研究组 & 干预措施
AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
干预措施: AMG 655 (Drug)
AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
干预措施: Modified FOLFOX6 (Drug)
AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
干预措施: Bevacizumab (Drug)
Placebo
Placebo + mFOLFOX6 + Bevacizumab
干预措施: Placebo (Drug)
Placebo
Placebo + mFOLFOX6 + Bevacizumab
干预措施: Modified FOLFOX6 (Drug)
Placebo
Placebo + mFOLFOX6 + Bevacizumab
干预措施: Bevacizumab (Drug)
AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
干预措施: AMG 655 (Drug)
AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
干预措施: Modified FOLFOX6 (Drug)
AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Length of study
次要结局
- Objective response rate(Length of study)
- Duration of response(Length of study)
- Time-to-response(Length of study)
- Overall survival(Length of study)
- AMG 655 pharmacokinetic parameters(Length of study)
- The incidence of anti-AMG 655 antibody formation(Length of study)