NCT00502060已完成1 期
A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839
研究概览
简要总结
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •tumor progressed on standard therapy or ineligible for standard therapy
- •life expectancy of 12 weeks or more
- •WHO performance status 0-2
排除标准
- •History of active interstitial lung disease
结局指标
主要结局
primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839
次要结局
- to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days
研究者
研究点 (3)
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