An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) Administered at Cycle 1 as a 60-minute Intravenous Infusion to Patients With Advanced Solid Tumors Followed by Extended Treatment With BSI-201 With or Without Additional Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
研究概览
简要总结
This is a Phase 1, multi-center, open-label study.
During Segment 1, patients are administered a single IV administration of [14C]-iniparib.
During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
iniparib
Segment 1: 400 mg [14C]-iniparib single administration
Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy
干预措施: Iniparib (Drug)
结局指标
主要结局
The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
时间窗: Up to 35 days
The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.
时间窗: Up to 35 days
The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity
时间窗: up to 35 days
The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration
时间窗: 96 hours
次要结局
- The clinical and biological tolerability of iniparib.(During treatment and until 30 days post treatment)