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Iniparib

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

Ensayo de Sanofi en Breast Cancer, Metastatic (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

163

previstos

Centros

20

Fin del objetivo primario

mar 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2010.

Qué mide

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)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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).

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Ficha completa en ClinicalTrials.gov (NCT01045304), actualizada en ene 2014.