drugset / Trial / NCT01161836
An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
NaSingle-groupOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2010-07
- Primary completion
- 2011-02
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iniparib | Small molecule | 5.6 mg/kg | Intravenous |
| Subject | Iniparib | Small molecule | 400 mg | Intravenous |