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)

NCT01161836

Phase 1 Completed 7 enrolled Sanofi
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

EvaluationDrugModalityDoseRoute
Subject Iniparib Small molecule 5.6 mg/kg Intravenous
Subject Iniparib Small molecule 400 mg Intravenous

Indications