A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and carboplatin.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Access to an investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer|
- To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: Until progressive disease or death ] [ Designated as safety issue: No ]
- To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: 30 days after last BSI-201 exposure ] [ Designated as safety issue: Yes ]
- To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: until progressive disease or death ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
BSI-201 in combination with gemcitabine and carboplatin.
IV infusion, 5.6 mg/kg
Other Name: PARP inhibitor
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033123
|United States, Massachusetts|
|Massachusetts Ceneral Hospital|
|Boston, Massachusetts, United States, 02114|
|Study Director:||Clinical Sciences & Operations||Sanofi|