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- to assess the objective response rate (ORR) of 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 gemcitabine/cisplatin/SAR240550 (GCS) and of the standard regimen gemcitabine/cisplatin (GC) alone
- 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 SAR240550 on PAR level in peripheral blood mononuclear cells (PBMC).
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-small Cell Lung Cancer Stage IV
SAR240550 (BSI-201), gemcitabine, cisplatin
Sanofi-Aventis Investigational Site Number 250002
Published on BioPortfolio: 2014-08-27T03:15:16-0400
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