NCT00473616终止1 期
A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
研究概览
简要总结
This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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.
- •Must be suitable for treatment with irinotecan
- •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
- •Any prior anthracycline treatment
研究组 & 干预措施
1
Experimental
AZD7762 monotherapy followed by AZD7762 + irinotecan
干预措施: AZD7762 (Drug)
1
Experimental
AZD7762 monotherapy followed by AZD7762 + irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
时间窗: assessed after each course of treatment
次要结局
- To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.(assessed after each course of treatment)
研究者
研究点 (2)
Loading locations...
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