An Open-Label Cardiac Safety Study of Tivozanib to Evaluate the Electrocardiogram and Pharmacokinetic-Electrocardiogram Dynamics in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Change from baseline in QTcF
研究概览
简要总结
The purpose of this study is to obtain QTc data, to assess the effects of tivozanib on ECG morphology, and to determine the pharmacokinetic pharmacodynamic (PK-PD) relationship between any observed changes in cardiac repolarization (defined by QTcF duration) and the serum concentration of tivozanib.
详细描述
Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity.
This study is an open-label, non-randomized, exploratory single-arm trial evaluating the ECG and pharmacokinetic (PK)-ECG relationship, if any, of tivozanib in subjects with advanced solid tumors.
The purpose of this study is to evaluate the ECG intervals and morphology following treatment with tivozanib in subjects with advanced solid tumors and to determine the relationship, if any, of the change in QTc duration with serum concentration of tivozanib over time in subjects with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
tivozanib
干预措施: tivozanib (Drug)
结局指标
主要结局
Change from baseline in QTcF
时间窗: 22 days
次要结局
- Change from baseline in QTc with Bazett correction method (QTcB)(22 days)
- Change from baseline in heart rate (HR)(22 days)
- Change from baseline in PR interval(22 days)
- Change from baseline in QRS interval(22 days)
- Change from baseline in Uncorrected QT interval(22 days)
- Change from baseline in ECG morphological patterns(22 days)
- Correlation between the QTcF change from baseline and serum concentrations of tivozanib(22 days)