jRCT2080220802未知1 期
A Phase 1, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
适应症
试验速览
- 阶段
- 1 期
- 发起方
- AstraZeneca
- 入组人数
- 45
- 主要终点
- Adverse events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
入排标准
- 年龄范围
- 20age old over 至 74age old under（—）
- 性别
- All
入选标准
- •Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective
- •Must be suitable for treatment with gemcitabine
- •Relatively good overall health other than cancer
排除标准
- •Poor bone marrow function (not producing enough blood cells)
- •Poor liver or kidney function
- •Serious heart conditions
结局指标
主要结局
Adverse events
Assessment of adverse events based on CTCAE version 3.0
Laboratory values
Assessment of laboratory values
Vital sign measurements
Assessment of vital sign measurements
Cardiac markers
Assessment of cardiac markers
ECG
Assessment of ECG
Echocardiogram
Assessment of Echocardiogram
次要结局
未报告次要终点
研究者
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