NCT00876044已完成1 期
A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- ECG parameters (QTcF interval)
研究概览
简要总结
The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients.
Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.
详细描述
All patients receive background treatment with docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
4 mg/kg every 2 weeks
干预措施: aflibercept (AVE0005) (Drug)
2
Placebo Comparator
matching placebo
干预措施: placebo (Drug)
结局指标
主要结局
ECG parameters (QTcF interval)
时间窗: Cycle 1 and Cycle 3
次要结局
- Other ECG parameters(Cycle 1 and Cycle 3)
- Clinical safety (adverse events, serious adverse events)(maximum of 15 cycles)
- Pharmacokinetic parameters(Cycle 1 and Cycle 3)
研究者
研究点 (1)
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