Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer
- Conditions
- Breast Cancer, Metastatic
- Interventions
- Registration Number
- NCT01045304
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a 60min intravenous (IV) infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC).
Secondary Objectives:
* To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks;
* To assess Progression-free survival (PFS) and the overall survival (OS);
* To assess the safety profile of each schedule of iniparib;
* To assess the biological activity in tumor tissue (substudy);
* To evaluate the pharmacokinetic (PK) profile of iniparib (substudy);
* To characterize molecular and biological profile of tumors (substudy);
* To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood mononuclear cells (PBMC) (substudy).
- Detailed Description
The duration of the study for a patient includes a period for inclusion of up to 3 weeks. The patients may continue treatment until disease progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment administration.
In case of discontinuation of study treatment, the patient will be considered as withdrawn from study treatment, and will be followed as planned for at least 30 days after the last administration of study treatment for safety purpose.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 until death or end of study.
The patients who benefit from the study treatment can continue until disease progression, toxicity or willingness to stop.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 163
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gencitabine + iniparib twice weekly Iniparib Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 5.6 mg/kg IV over 60 minutes on Days 1, 4, 8 and 11 of 3-week cycles Gencitabine + iniparib twice weekly Gemcitabine Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 5.6 mg/kg IV over 60 minutes on Days 1, 4, 8 and 11 of 3-week cycles Gencitabine + iniparib twice weekly Carboplatin Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 5.6 mg/kg IV over 60 minutes on Days 1, 4, 8 and 11 of 3-week cycles Gencitabine + iniparib weekly Iniparib Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 11.2 mg/kg IV over 60 minutes on Days 1 and 8 of 3-week cycles Gencitabine + iniparib weekly Carboplatin Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 11.2 mg/kg IV over 60 minutes on Days 1 and 8 of 3-week cycles Gencitabine + iniparib weekly Gemcitabine Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 11.2 mg/kg IV over 60 minutes on Days 1 and 8 of 3-week cycles
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) Up the cut-off date for analysis defined as 16 weeks after the 1st dose in the last participant (maximum follow-up of 14 months) Proportion of participants with confirmed complete response (CR) or partial response (PR) as confirmed by an Independent Radiology Review Committee (IRRC) based on central review of scans in a blinded manner.
- Secondary Outcome Measures
Name Time Method Progression-free survival Up the cut-off date for analysis defined as 16 weeks after the 1st dose in the last participant (maximum follow-up of 14 months) Number of days from the date of randomization to the date of disease progression (ie, radiological progression based on IRRC assessment) or the date of death (from any cause), whichever is earlier.
Overall survival Up the cut-off date for analysis defined as 16 weeks after the 1st dose in the last participant (maximum follow-up of 14 months) Clinical benefit rate (CBR) Up the cut-off date for analysis defined as 16 weeks after the 1st dose in the last participant (maximum follow-up of 14 months) Proportion of participants with confirmed complete response (CR) or partial response (PR) ot stable disease (SD) greater than 24 weeks as confirmed by the IRRC.
Trial Locations
- Locations (20)
Sanofi-Aventis Investigational Site Number 250001
🇫🇷Toulouse, France
Sanofi-Aventis Investigational Site Number 036003
🇦🇺Westmead, Australia
Sanofi-Aventis Investigational Site Number 250005
🇫🇷Besancon Cedex, France
Sanofi-Aventis Investigational Site Number 250002
🇫🇷Dijon, France
Sanofi-Aventis Investigational Site Number 250006
🇫🇷Paris Cedex 05, France
Sanofi-Aventis Investigational Site Number 036001
🇦🇺Perth, Australia
Sanofi-Aventis Investigational Site Number 724004
🇪🇸Madrid, Spain
Sanofi-Aventis Investigational Site Number 250004
🇫🇷Paris, France
Sanofi-Aventis Investigational Site Number 036002
🇦🇺Parkville, Australia
Sanofi-Aventis Investigational Site Number 250003
🇫🇷Bordeaux, France
Sanofi-Aventis Investigational Site Number 724002
🇪🇸Barcelona, Spain
Sanofi-Aventis Investigational Site Number 724001
🇪🇸Málaga, Spain
Sanofi-Aventis Investigational Site Number 380001
🇮🇹Milano, Italy
Sanofi-Aventis Investigational Site Number 380002
🇮🇹Modena, Italy
Sanofi-Aventis Investigational Site Number 380003
🇮🇹Udine, Italy
Sanofi-Aventis Investigational Site Number 380004
🇮🇹Genova, Italy
Sanofi-Aventis Investigational Site Number 724003
🇪🇸Valencia, Spain
Sanofi-Aventis Investigational Site Number 056002
🇧🇪Leuven, Belgium
Sanofi-Aventis Investigational Site Number 528001
🇳🇱Rotterdam, Netherlands
Sanofi-Aventis Investigational Site Number 056001
🇧🇪Bruxelles, Belgium