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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
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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 7 |
| Start date | 2010-07 |
| Completion | 2011-06 |
Conditions
- Advanced Solid Tumors
Interventions
- Iniparib
Primary outcomes
- The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib — 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 — up to 35 days
- The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration — 96 hours
- The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. — Up to 35 days
Countries
United States