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

AstraZeneca2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2005年10月最近更新: 2009年6月12日

适应症

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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

AstraZeneca

申办方类型

Industry

研究点 (2)

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