NCT01418222已完成2 期
Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 23
- 主要终点
- Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 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
- •Adult patients, >/= 18 years of age
- •Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Measurable disease by RECIST criteria
- •Adequate organ system function, as defined by protocol
排除标准
- •Prior systemic or radiation therapy for metastatic colorectal cancer
- •Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
- •Previously untreated brain metastases
- •History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
- •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- •History of hematemesis or hemoptysis </= 1 months prior to study enrollment
- •Significant cardiovascular disease or disorder
- •History of abdominal fistula or gastrointestinal perforation </= 6 months prior to Day 1
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer
研究组 & 干预措施
A
Experimental
干预措施: 5-FU (Drug)
A
Experimental
干预措施: FOLFOX regimen (Drug)
A
Experimental
干预措施: bevacizumab [Avastin] (Drug)
A
Experimental
干预措施: leucovorin (Drug)
A
Experimental
干预措施: onartuzumab [MetMAb] (Drug)
B
Active Comparator
干预措施: 5-FU (Drug)
B
Active Comparator
干预措施: FOLFOX regimen (Drug)
B
Active Comparator
干预措施: Placebo (Drug)
B
Active Comparator
干预措施: bevacizumab [Avastin] (Drug)
B
Active Comparator
干预措施: leucovorin (Drug)
结局指标
主要结局
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
时间窗: up to 4 years
次要结局
- Response rate (complete response + partial response)(up to 4 years)
- Overall survival(up to 4 years)
- Safety: Incidence of adverse events(up to 4 years)
- Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death(up to 4 years)
研究者
研究点 (23)
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