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Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer

Primary Purpose

Breast Cancer, Metastatic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Iniparib
Gemcitabine
Carboplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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);

  • 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.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 036002
  • Sanofi-Aventis Investigational Site Number 036001
  • Sanofi-Aventis Investigational Site Number 036003
  • Sanofi-Aventis Investigational Site Number 056001
  • Sanofi-Aventis Investigational Site Number 056002
  • Sanofi-Aventis Investigational Site Number 250005
  • Sanofi-Aventis Investigational Site Number 250003
  • Sanofi-Aventis Investigational Site Number 250002
  • Sanofi-Aventis Investigational Site Number 250006
  • Sanofi-Aventis Investigational Site Number 250004
  • Sanofi-Aventis Investigational Site Number 250001
  • Sanofi-Aventis Investigational Site Number 380004
  • Sanofi-Aventis Investigational Site Number 380001
  • Sanofi-Aventis Investigational Site Number 380002
  • Sanofi-Aventis Investigational Site Number 380003
  • Sanofi-Aventis Investigational Site Number 528001
  • Sanofi-Aventis Investigational Site Number 724002
  • Sanofi-Aventis Investigational Site Number 724004
  • Sanofi-Aventis Investigational Site Number 724001
  • Sanofi-Aventis Investigational Site Number 724003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gencitabine + iniparib twice weekly

Gencitabine + iniparib weekly

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
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

Clinical benefit rate (CBR)
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
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

Full Information

First Posted
January 7, 2010
Last Updated
January 13, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01045304
Brief Title
Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gencitabine + iniparib twice weekly
Arm Type
Experimental
Arm Description
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
Arm Title
Gencitabine + iniparib weekly
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Iniparib
Other Intervention Name(s)
SAR240550, BSI-201
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: intravenous
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: intravenous
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Clinical benefit rate (CBR)
Description
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.
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)
Title
Progression-free survival
Description
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.
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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); 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 036002
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 036001
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 036003
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 056001
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056002
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 250005
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250003
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250002
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250006
City
Paris Cedex 05
ZIP/Postal Code
75231
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250004
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250001
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 380004
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380001
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380002
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380003
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 528001
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724004
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724001
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724003
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31172407
Citation
Dieras V, Bonnefoi H, Alba E, Awada A, Coudert B, Pivot X, Gligorov J, Jager A, Zambelli S, Lindeman GJ, Charpentier E, Emmons GT, Garcia-Ribas I, Paridaens R, Verweij J. Iniparib administered weekly or twice-weekly in combination with gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer: a phase II randomized open-label study with pharmacokinetics. Breast Cancer Res Treat. 2019 Sep;177(2):383-393. doi: 10.1007/s10549-019-05305-w. Epub 2019 Jun 6.
Results Reference
derived

Learn more about this trial

Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer

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