Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer
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| ClinicalTrials.gov Identifier: NCT01045304 |
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Recruitment Status :
Completed
First Posted : January 11, 2010
Last Update Posted : January 14, 2014
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer, Metastatic | Drug: Iniparib Drug: Gemcitabine Drug: Carboplatin | Phase 2 |
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In case of discontinuation of study treatment, the patient will be considered as withdrawn from study treatment, and will be followed as planned for at least 30 days after the last administration of study treatment for safety purpose.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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 163 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC) |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | November 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Gencitabine + iniparib twice weekly
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 |
Drug: Iniparib
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Names:
Drug: Gemcitabine Pharmaceutical form: solution for infusion Route of administration: intravenous Drug: Carboplatin Pharmaceutical form: solution for infusion Route of administration: intravenous |
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Experimental: Gencitabine + iniparib weekly
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 |
Drug: Iniparib
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Names:
Drug: Gemcitabine Pharmaceutical form: solution for infusion Route of administration: intravenous Drug: Carboplatin Pharmaceutical form: solution for infusion Route of administration: intravenous |
- Overall response rate (ORR) [ Time Frame: 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.
- Clinical benefit rate (CBR) [ Time Frame: 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.
- Progression-free survival [ Time Frame: 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 [ Time Frame: 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) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Histologically documented breast cancer (either primary or metastatic site) that is ER (estrogen receptor)-negative, PgR (progesterone receptor)-negative ( <10% tumor staining by immunohistochemistry [IHC]) and HER2 (human epidermal growth factor 2) non-overexpressing by IHC (0,1+) or, IHC 2+ and FISH (fluorescence In situ hybridization) negative.
- Metastatic breast cancer with measurable disease by the revised guideline for Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1 criteria);
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Prior treatment that includes:
- never having received anticancer therapy for metastatic disease OR
- having received 1 or 2 prior chemotherapy regimens in the metastatic setting (prior neo-adjuvant/adjuvant systemic therapy is considered as a prior chemotherapy if the first relapse occurred less than one year after the last treatment administration).
Exclusion criteria:
- Prior treatment with gemcitabine, carboplatin, cisplatin or any PARP inhibitor;
- Bone metastasis as only disease location (except for bone metastasis with measurable soft tissue component);
- Major medical conditions that might affect study participation e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045304
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| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01045304 |
| Other Study ID Numbers: |
TCD11418 2009-016091-80 ( EudraCT Number ) |
| First Posted: | January 11, 2010 Key Record Dates |
| Last Update Posted: | January 14, 2014 |
| Last Verified: | January 2014 |
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Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carboplatin Gemcitabine |
Iniparib Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |