Non-small Cell Lung Cancer Stage IV Clinical Trial
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
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.)
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
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