An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
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.
Access to an investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||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|
- The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
- The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]
- The clinical and biological tolerability of iniparib. [ Time Frame: During treatment and until 30 days post treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Segment 1: 400 mg [14C]-iniparib single administration
Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy
Solution for infusion
60-minute intravenous infusion
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161836
|United States, Washington|
|Northwest Medical Specialties|
|Tacoma, Washington, United States, 98405|
|Study Director:||Clinical Sciences & Operations||Sanofi|