A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 13
- 主要终点
- Progression free survival based on tumor assessments (CT/MRI)
研究概览
简要总结
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ECOG Performance Status (PS) ≤1
- •Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
- •Measurable disease by RECIST guidelines
- •Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
- •Available paraffin embedded tumor tissue
- •Willing to give a whole blood sample for the study of proteins and genetic polymorphisms
排除标准
- •Less than 28 days elapsed since major surgery at time of randomization
- •Known CNS metastases
- •Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
- •Uncontrolled hypertension
- •Clinically significant cardiovascular disease
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
- •Known HIV Positive
研究组 & 干预措施
Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
干预措施: Irinotecan (Drug)
Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
干预措施: 5-Fluorouracil (bolus) (Drug)
Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
干预措施: 5-Fluorouracil (infusional) (Drug)
Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
干预措施: Leucovorin calcium (Drug)
Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
干预措施: CT-322 (Drug)
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
干预措施: Irinotecan (Drug)
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
干预措施: 5-Fluorouracil (bolus) (Drug)
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
干预措施: 5-Fluorouracil (infusional) (Drug)
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
干预措施: Leucovorin calcium (Drug)
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
干预措施: Bevacizumab (Drug)
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
干预措施: Bevacizumab Placebo (saline solution) (Drug)
结局指标
主要结局
Progression free survival based on tumor assessments (CT/MRI)
时间窗: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
次要结局
- Overall survival (OS), defined as the time the subject is randomized until death, in each arm(every 12 weeks)
- Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator(every 6 weeks)
- Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects(weekly)