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
18 Years
65 Years
Both
Advanced Solid Tumors
Trial Information
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
Inclusion Criteria
Male or female patients with advanced solid tumors that are refractory to standard
treatment or for which no standard treatment exists; patients must be at least 18 years
old.
Additional criteria are also required and should be evaluated by the research staff.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
Outcome Time Frame:
Up to 35 days
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
BEX11505
NCT ID:
NCT01161836
Start Date:
July 2010
Completion Date:
June 2011
Related Keywords:
- Advanced Solid Tumors
Name | Location |
|---|---|
| Northwest Medical Specialties | Tacoma, Washington 98405 |
