Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer

NCT01086254 Phase 2 COMPLETED

Primary Objective: * to assess the objective response rate (ORR) of Iniparib (SAR240550) administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabine/cisplatin (GC) in patients with stage IV non small cell lung cancer. Secondary objectives are: * to assess the safety profiles of the study combination GCS and of the standard regimen GC; * to assess the progression free survival and the overall survival in both arms; * to assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease. * to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells (PBMC). (As of 10 September 2010, the collection of PBMC is temporarily discontinued.)

Details

Lead sponsor	Sanofi
Phase	Phase 2
Status	COMPLETED
Enrolment	119
Start date	2010-05
Completion	2011-12

Conditions

• Non-small Cell Lung Cancer Stage IV

Interventions

• Iniparib
• gemcitabine
• cisplatin

Primary outcomes

• overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate — up to a maximum follow-up of 25 weeks

Countries

France, Germany, Italy, Spain, United Kingdom