A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01033292|
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : March 17, 2016
The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant 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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: BSI-201||Phase 2|
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 :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
BSI-201 in combination with gemcitabine and carboplatin.
IV infusion, 5.6 mg/kg
Other Name: PARP inhibitor
- To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: Until progressive disease or death ]
- 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 ]
- To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: until progressive disease or death ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033292
|United States, Massachusetts|
|Massachusetts Ceneral Hospital|
|Boston, Massachusetts, United States, 02114|
|Study Director:||Clinical Sciences & Operations||Sanofi|