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
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria:

• Histologically documented breast cancer (either primary or metastatic site) that is ER (estrogen receptor)-negative, PgR (progesterone receptor)-negative ( <10% tumor staining by immunohistochemistry [IHC]) and HER2 (human epidermal growth factor 2) non-overexpressing by IHC (0,1+) or, IHC 2+ and FISH (fluorescence In situ hybridization) negative.

• Metastatic breast cancer with measurable disease by the revised guideline for Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1 criteria);

• Prior treatment that includes:

• never having received anticancer therapy for metastatic disease OR

• having received 1 or 2 prior chemotherapy regimens in the metastatic setting (prior neo-adjuvant/adjuvant systemic therapy is considered as a prior chemotherapy if the first relapse occurred less than one year after the last treatment administration).

Exclusion criteria:

• Prior treatment with gemcitabine, carboplatin, cisplatin or any PARP inhibitor;

• Bone metastasis as only disease location (except for bone metastasis with measurable soft tissue component);

• Major medical conditions that might affect study participation e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.