NCT02780700终止2 期
LUME-Colon 2: An Open-label Randomized Phase II Study to Assess the Efficacy and Safety of Nintedanib Alone or in Combination With Capecitabine for Patients With Refractory Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The objective of this Phase II study is to assess the efficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer (mCRC) after failure of at least 2 lines of standard treatment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nintedanib
Experimental
干预措施: Nintedanib (Drug)
Nintedanib plus capecitabine
Experimental
干预措施: Nintedanib (Drug)
Nintedanib plus capecitabine
Experimental
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
PFS is defined as the time from randomization until objective tumor progression or death. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.
次要结局
- Overall Survival (OS)(Data collected up to cut-off date 09 Sep 2016, Up to 02 months)
- Objective Response Rate (ORR)(tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.)
- Disease Control (DC)(Data collected up to cut-off date 09 Sep 2016, Up to 02 months)
- Percentage of Patients With Grade 3 or Worse Adverse Events(Data collected up to cut-off date 09 Sep 2016, Up to 02 months)
研究者
研究点 (1)
Loading locations...
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