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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
iniparib
Segment 1: 400 mg [14C]-iniparib single administration
Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy
Intervention: Iniparib (Drug)
Outcomes
Primary Outcomes
The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
Time Frame: Up to 35 days
The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.
Time Frame: 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
Time Frame: up to 35 days
The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration
Time Frame: 96 hours
Secondary Outcomes
- The clinical and biological tolerability of iniparib.(During treatment and until 30 days post treatment)