SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer

Summary

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.)

Timeline

Start

2010-05

Primary completion

2011-12

Completion

2011-12

Publications

• Novello S, Besse B, Felip E, Barlesi F, Mazieres J, Zalcman G, von Pawel J, Reck M, Cappuzzo F, Ferry D, Carcereny E, Santoro A, Garcia-Ribas I, Scagliotti G, Soria JC. A phase II randomized study evaluating the addition of iniparib to gemcitabine plus cisplatin as first-line therapy for metastatic non-small-cell lung cancer. Ann Oncol. 2014 Nov;25(11):2156-2162. doi: 10.1093/annonc/mdu384. Epub 2014 Aug 19.

Drugs

Indications