NCT00389389已完成1 期
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients 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
- 75
- 试验地点
- 3
- 主要终点
- To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.
研究概览
简要总结
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis
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
- •Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
- •Relatively good overall health other than your cancer.
排除标准
- •Poor bone marrow function (not producing enough blood cells).
- •Serious heart conditions.
- •Poor liver or kidney function.
结局指标
主要结局
To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.
时间窗: assessed at each treatment
次要结局
- Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.(Assessed after the first course of treatment)
研究者
研究点 (3)
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