Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2010
Primary Objective: * To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a 60min intravenous (IV) infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC). Secondary Objectives: * To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks; * To assess Progression-free survival (PFS) and the overall survival (OS); * To assess the safety profile of each schedule of iniparib; * To assess the biological activity in tumor tissue (substudy); * To evaluate the pharmacokinetic (PK) profile of iniparib (substudy); * To characterize molecular and biological profile of tumors (substudy); * To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood mononuclear cells (PBMC) (substudy).
Epistemonikos ID: 174a309683dce968a39f51c789708ac6882e1fc5
First added on: May 05, 2024