NCT00707889已完成2 期
An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer
AbbVie (prior sponsor, Abbott)46 个研究点 分布在 14 个国家目标入组 159 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 46
- 主要终点
- Progression-free survival
研究概览
简要总结
To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced 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
- None
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
- •Subject must be >/= 18 years of age. Subject (male or female) must be diagnosed with adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.
- •Subject must have received one prior chemotherapy regimen containing irinotecan or a fluoropyrimidine for locally recurrent or metastatic colon or rectal cancer.
- •Subject has experienced progressive disease during or following the previous anti-tumor treatment.
- •Subject may have received prior adjuvant treatment for colorectal cancer. Subject has measurable disease by RECIST criteria (randomized portion only). Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-
- •Subject must have adequate bone marrow, renal and hepatic function. Subject must have Partial Thromboplastin Time (PTT) < 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) < 1.5.
排除标准
- •Subject has received more than one prior therapy in the metastatic setting. Lead-in Cohort only: The subject may have received more than one prior therapy in the metastatic setting.
- •Subject has received cytotoxic chemotherapy within 21 days prior to Study Day
- •Subject has received non-cytotoxic, anti-cancer therapy within 21 days or within a period defined by 5 half lives whichever is shorter, prior to Study Day
- •Subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
- •Subject has received prior treatment with a tyrosine kinase inhibitor targeting VEGF or PDGF.
- •Subject has received prior treatment with oxaliplatin in the metastatic setting. Lead-in cohort only: Prior treatment with oxaliplatin will be allowed provided that any neuropathy as a result of the oxaliplatin treatment has resolved to less than or equal to Grade
- •Subject has had major surgery within 28 days of Study Day
- •Subject has had radiotherapy within 14 days of Study Day
- •Subject has a history of hypersensitivity to recombinant murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds, fluorouracil, or folinic acid.
- •Subject has a known intolerance to bevacizumab. Subject has untreated brain or meningeal metastases. Subject is receiving therapeutic anticoagulation therapy . Subject has a history of/or currently exhibits clinically significant cancer related events of bleeding.
- •Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
- •Subject has a history of myocardial infarction, stroke, or transient ischemic attack within six months of Study Day
- •History of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.
研究组 & 干预措施
B
Active Comparator
Open-label to High-dose ABT-869 arm plus mFOLFOX6
干预措施: fluorouracil (Drug)
A
Active Comparator
Open-label to Bevacizumab plus mFOLFOX6
干预措施: bevacizumab (Drug)
A
Active Comparator
Open-label to Bevacizumab plus mFOLFOX6
干预措施: oxaliplatin (Drug)
A
Active Comparator
Open-label to Bevacizumab plus mFOLFOX6
干预措施: folinic acid (Drug)
A
Active Comparator
Open-label to Bevacizumab plus mFOLFOX6
干预措施: fluorouracil (Drug)
B
Active Comparator
Open-label to High-dose ABT-869 arm plus mFOLFOX6
干预措施: ABT-869 (Drug)
B
Active Comparator
Open-label to High-dose ABT-869 arm plus mFOLFOX6
干预措施: oxaliplatin (Drug)
B
Active Comparator
Open-label to High-dose ABT-869 arm plus mFOLFOX6
干预措施: folinic acid (Drug)
C
Active Comparator
Open-label to low-dose ABT-869 arm plus mFOLFOX6
干预措施: oxaliplatin (Drug)
C
Active Comparator
Open-label to low-dose ABT-869 arm plus mFOLFOX6
干预措施: folinic acid (Drug)
C
Active Comparator
Open-label to low-dose ABT-869 arm plus mFOLFOX6
干预措施: fluorouracil (Drug)
C
Active Comparator
Open-label to low-dose ABT-869 arm plus mFOLFOX6
干预措施: ABT-869 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks
次要结局
- Overall survival(from randomization until patient death or alive at 5 years)
- 12-month overall survival rate(from randomization until patient death or alive at 5 years)
- Objective response rate(from randomization until patient death or alive at 5 years)
研究者
研究点 (46)
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