NCT00507091已完成1 期
A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
研究概览
简要总结
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic 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
- •Confirmed metastatic colorectal adenocarcinoma
- •Not amenable to surgery or radiation therapy
- •Eligible for first or second line chemotherapy
排除标准
- •Brain metastases or spinal compression
- •Last prior chemotherapy discontinued within 4 weeks before start
- •Last dose radiotherapy within 4 weeks of start
研究组 & 干预措施
ZD6474 (vandetanib) 300mg
Experimental
干预措施: 5-Fluorouracil (Drug)
ZD6474 (vandetanib) 100mg
Experimental
干预措施: ZD6474 (vandetanib) 100mg (Drug)
ZD6474 (vandetanib) 100mg
Experimental
干预措施: Irinotecan (Drug)
ZD6474 (vandetanib) 100mg
Experimental
干预措施: 5-Fluorouracil (Drug)
ZD6474 (vandetanib) 100mg
Experimental
干预措施: Leucovorin (Drug)
ZD6474 (vandetanib) 300mg
Experimental
干预措施: Irinotecan (Drug)
ZD6474 (vandetanib) 300mg
Experimental
干预措施: Leucovorin (Drug)
ZD6474 (vandetanib) 300mg
Experimental
干预措施: ZD6474 (vandetanib) 300mg (Drug)
结局指标
主要结局
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
时间窗: assessed at each visit
次要结局
未报告次要终点
研究者
研究点 (1)
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