NCT01271166终止1 期
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tumour response as assessed by CT scan and RESIST
研究概览
简要总结
This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
- •ECOG 0 or 1
- •Measurable disease
排除标准
- •Prior first line therapy for advanced disease
- •Significant bulk of metastatic disease or rapid progression
- •If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Glivec®, modified FOLFOX, Avastin®
Experimental
干预措施: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab (Drug)
结局指标
主要结局
Tumour response as assessed by CT scan and RESIST
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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