NCT01045304

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2010

Geographic Reach
6 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

January 7, 2010

Last Update Submit

January 13, 2014

Conditions

Breast Cancer, Metastatic

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Gencitabine + iniparib twice weekly

EXPERIMENTAL

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: IniparibDrug: GemcitabineDrug: Carboplatin

Gencitabine + iniparib weekly

EXPERIMENTAL

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: IniparibDrug: GemcitabineDrug: Carboplatin

Interventions

IniparibDRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Also known as: SAR240550, BSI-201
Gencitabine + iniparib twice weeklyGencitabine + iniparib weekly
GemcitabineDRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Gencitabine + iniparib twice weeklyGencitabine + iniparib weekly
CarboplatinDRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Gencitabine + iniparib twice weeklyGencitabine + iniparib weekly

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Sanofi-Aventis Investigational Site Number 036002

Parkville, 3052, Australia

Location

Sanofi-Aventis Investigational Site Number 036001

Perth, 6000, Australia

Location

Sanofi-Aventis Investigational Site Number 036003

Westmead, 2145, Australia

Location

Sanofi-Aventis Investigational Site Number 056001

Brussels, 1000, Belgium

Location

Sanofi-Aventis Investigational Site Number 056002

Leuven, 3000, Belgium

Location

Sanofi-Aventis Investigational Site Number 250005

Besançon, 25030, France

Location

Sanofi-Aventis Investigational Site Number 250003

Bordeaux, 33076, France

Location

Sanofi-Aventis Investigational Site Number 250002

Dijon, 21034, France

Location

Sanofi-Aventis Investigational Site Number 250006

Paris, 75231, France

Location

Sanofi-Aventis Investigational Site Number 250004

Paris, 75970, France

Location

Sanofi-Aventis Investigational Site Number 250001

Toulouse, 31052, France

Location

Sanofi-Aventis Investigational Site Number 380004

Genova, 16132, Italy

Location

Sanofi-Aventis Investigational Site Number 380001

Milan, 20133, Italy

Location

Sanofi-Aventis Investigational Site Number 380002

Modena, 41100, Italy

Location

Sanofi-Aventis Investigational Site Number 380003

Udine, 33100, Italy

Location

Sanofi-Aventis Investigational Site Number 528001

Rotterdam, 3075 EA, Netherlands

Location

Sanofi-Aventis Investigational Site Number 724002

Barcelona, 08035, Spain

Location

Sanofi-Aventis Investigational Site Number 724004

Madrid, 28050, Spain

Location

Sanofi-Aventis Investigational Site Number 724001

Málaga, 29010, Spain

Location

Sanofi-Aventis Investigational Site Number 724003

Valencia, 46010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31172407DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

iniparibGemcitabineCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 11, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2011

Study Completion

November 1, 2012

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

NL(1)ES(4)FR(6)BE(2)IT(4)AU(3)