An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
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|ClinicalTrials.gov Identifier: NCT01161836|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : September 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: Iniparib||Phase 1|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||June 2011|
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
- The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib [ 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 ]
- The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. [ Time Frame: Up to 35 days ]
- The clinical and biological tolerability of iniparib. [ Time Frame: During treatment and until 30 days post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161836
|United States, Washington|
|Northwest Medical Specialties|
|Tacoma, Washington, United States, 98405|
|Study Director:||Clinical Sciences & Operations||Sanofi|