NCT00503477已完成1 期
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies
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
- 40
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced solid tumors
- •life expectancy is 12 weeks or longer
排除标准
- •patient with uncontrolled brain metastases
- •patient with inappropriate laboratory test values
- •patient with poorly controlled hypertension
结局指标
主要结局
Safety and tolerability
时间窗: Assessed at each visit for 4 weeks
次要结局
- efficacy, PK(Assessed at each visit for 4 weeks)
研究者
研究点 (2)
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