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

• Status: Completed
• Trial end date: 2012-11-01

Summary

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).

• Phase: Phase 2

Details

• Lead Sponsor: Sanofi
• Treatments: Carboplatin; Gemcitabine; Iniparib