SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Interventions
- Registration Number
- NCT01086254
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iniparib/ Gemcitabine/ Cisplatin cisplatin Iniparib, 5.6 mg/kg, 60-min IV infusion twice weekly (days 1, 4, 8, and 11). Infusion starts after completion of GC regimen administration. Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. Iniparib/ Gemcitabine/ Cisplatin Iniparib Iniparib, 5.6 mg/kg, 60-min IV infusion twice weekly (days 1, 4, 8, and 11). Infusion starts after completion of GC regimen administration. Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. Iniparib/ Gemcitabine/ Cisplatin gemcitabine Iniparib, 5.6 mg/kg, 60-min IV infusion twice weekly (days 1, 4, 8, and 11). Infusion starts after completion of GC regimen administration. Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. Gemcitabine/ Cisplatin cisplatin Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. Gemcitabine/ Cisplatin gemcitabine Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion.
- Primary Outcome Measures
Name Time Method overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate up to a maximum follow-up of 25 weeks
- Secondary Outcome Measures
Name Time Method progression free survival up to a maximum of 2 years overall survival up to a maximum of 2 years
Trial Locations
- Locations (14)
Sanofi-Aventis Investigational Site Number 250003
🇫🇷Marseille Cedex 09, France
Sanofi-Aventis Investigational Site Number 250002
🇫🇷Caen Cedex, France
Sanofi-Aventis Investigational Site Number 276003
🇩🇪Essen, Germany
Sanofi-Aventis Investigational Site Number 380001
🇮🇹Orbassano, Italy
Sanofi-Aventis Investigational Site Number 250001
🇫🇷Villejuif, France
Sanofi-Aventis Investigational Site Number 826002
🇬🇧Wolverhampton, United Kingdom
Sanofi-Aventis Investigational Site Number 250004
🇫🇷Toulouse, France
Sanofi-Aventis Investigational Site Number 276001
🇩🇪Großhansdorf, Germany
Sanofi-Aventis Investigational Site Number 380003
🇮🇹Livorno, Italy
Sanofi-Aventis Investigational Site Number 276002
🇩🇪Gauting, Germany
Sanofi-Aventis Investigational Site Number 724001
🇪🇸Badalona, Spain
Sanofi-Aventis Investigational Site Number 380002
🇮🇹Rozzano, Italy
Sanofi-Aventis Investigational Site Number 724002
🇪🇸Barcelona, Spain
Sanofi-Aventis Investigational Site Number 826001
🇬🇧Newcastle Upon Tyne, United Kingdom