NCT00499850已完成1 期
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
Genzyme, a Sanofi Company4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
研究概览
简要总结
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 adenocarcinoma (Stage IV)
- •WHO performance status 0-1
- •one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques
排除标准
- •Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
- •last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
- •prior unanticipated severe reaction to oxaliplatin
结局指标
主要结局
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
时间窗: Assessed at each visit
次要结局
未报告次要终点
研究者
研究点 (4)
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