NCT01086254

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.)

Detailed description

The duration of the study for a patient will include a period for inclusion of up to 3 weeks. The patients may continue treatment up to a maximum of 6 cycles or until disease progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment administration. Patients will be followed for at least 30 days after the last administration of study treatment for safety purpose. In case of study treatment discontinuation without disease progression, efficacy data will be collected every 6 weeks until disease progression, death or end of study whatever comes first. After disease progression, the patient will be followed-up every 12 weeks (3 months) for overall survival (OS) until death or end of study whatever comes first. The end of the study will be one year after the first dose of the last treated patient.

Conditions

• Non-small Cell Lung Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Iniparib	Pharmaceutical form: solution for infusion Route of administration: 60-minute IV infusion
DRUG	gemcitabine	Pharmaceutical form: solution for infusion Route of administration: 30-minute IV infusion
DRUG	cisplatin	Pharmaceutical form: solution for infusion Route of administration: 1- to 4-hour IV infusion, according to the local standard

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-03-15
• Last updated: 2013-09-24

Locations

14 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom