Spots Global Cancer Trial Database for SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer
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Trial Identification
Brief Title: SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer
Official Title: 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
Study ID: NCT01086254
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Investigational Site Number 250002, Caen Cedex, , France
Sanofi-Aventis Investigational Site Number 250003, Marseille Cedex 09, , France
Sanofi-Aventis Investigational Site Number 250004, Toulouse, , France
Sanofi-Aventis Investigational Site Number 250001, Villejuif, , France
Sanofi-Aventis Investigational Site Number 276003, Essen, , Germany
Sanofi-Aventis Investigational Site Number 276002, Gauting, , Germany
Sanofi-Aventis Investigational Site Number 276001, Großhansdorf, , Germany
Sanofi-Aventis Investigational Site Number 380003, Livorno, , Italy
Sanofi-Aventis Investigational Site Number 380001, Orbassano, , Italy
Sanofi-Aventis Investigational Site Number 380002, Rozzano, , Italy
Sanofi-Aventis Investigational Site Number 724001, Badalona, , Spain
Sanofi-Aventis Investigational Site Number 724002, Barcelona, , Spain
Sanofi-Aventis Investigational Site Number 826001, Newcastle Upon Tyne, , United Kingdom
Sanofi-Aventis Investigational Site Number 826002, Wolverhampton, , United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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