Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)

NCT01045304 Phase 2 COMPLETED

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).

Details

Lead sponsor	Sanofi
Phase	Phase 2
Status	COMPLETED
Enrolment	163
Start date	2010-02
Completion	2012-11

Conditions

• Breast Cancer, Metastatic

Interventions

• Iniparib
• Gemcitabine
• Carboplatin

Primary outcomes

• Overall response rate (ORR) — Up the cut-off date for analysis defined as 16 weeks after the 1st dose in the last participant (maximum follow-up of 14 months)
  Proportion of participants with confirmed complete response (CR) or partial response (PR) as confirmed by an Independent Radiology Review Committee (IRRC) based on central review of scans in a blinded manner.

Countries

Australia, Belgium, France, Italy, Netherlands, Spain