SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.)