NCT00937664终止1 期
A Phase I, 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
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
- 24
- 试验地点
- 1
- 主要终点
- Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
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 AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
AZD7762 + gemcitabine
Other
AZD7762 administered alone and in combination with gemcitabine
干预措施: AZD7762 (Drug)
AZD7762 + gemcitabine
Other
AZD7762 administered alone and in combination with gemcitabine
干预措施: gemcitabine (Drug)
结局指标
主要结局
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
时间窗: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
次要结局
- Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine(According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1)
- Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)(Every 2-3 cycles)
研究者
研究点 (1)
Loading locations...
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