NCT01097018已完成3 期
A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
AEterna Zentaris2 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 468
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory 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
- 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
- •Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.
- •For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.
- •No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine
- •Patients must have at least one measurable lesion by RECIST criteria
排除标准
- •Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU
研究组 & 干预措施
Perifosine + Capecitabine
Active Comparator
Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
干预措施: Capecitabine (Drug)
Perifosine + Capecitabine
Active Comparator
Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
干预措施: Perifosine (Drug)
Placebo + Capecitabine
Placebo Comparator
Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
干预措施: Capecitabine (Drug)
Placebo + Capecitabine
Placebo Comparator
Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Monthly
次要结局
- Progression-free Survival(Every 6 weeks)
研究者
研究点 (2)
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