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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01045304




Registration number
NCT01045304
Ethics application status
Date submitted
7/01/2010
Date registered
11/01/2010
Date last updated
14/01/2014

Titles & IDs
Public title
Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer
Scientific 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)
Secondary ID [1] 0 0
2009-016091-80
Secondary ID [2] 0 0
TCD11418
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer, Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Iniparib
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin

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

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


Treatment: Drugs: Iniparib
Pharmaceutical form: solution for infusion
Route of administration: intravenous

Treatment: Drugs: Gemcitabine
Pharmaceutical form: solution for infusion
Route of administration: intravenous

Treatment: Drugs: Carboplatin
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR)
Timepoint [1] 0 0
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 [1] 0 0
Clinical benefit rate (CBR)
Timepoint [1] 0 0
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 [2] 0 0
Progression-free survival
Timepoint [2] 0 0
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 [3] 0 0
Overall survival
Timepoint [3] 0 0
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)

Eligibility
Key inclusion 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Investigational Site Number 036002 - Parkville
Recruitment hospital [2] 0 0
Sanofi-Aventis Investigational Site Number 036001 - Perth
Recruitment hospital [3] 0 0
Sanofi-Aventis Investigational Site Number 036003 - Westmead
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
France
State/province [3] 0 0
Besancon Cedex
Country [4] 0 0
France
State/province [4] 0 0
Bordeaux
Country [5] 0 0
France
State/province [5] 0 0
Dijon
Country [6] 0 0
France
State/province [6] 0 0
Paris Cedex 05
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Toulouse
Country [9] 0 0
Italy
State/province [9] 0 0
Genova
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Modena
Country [12] 0 0
Italy
State/province [12] 0 0
Udine
Country [13] 0 0
Netherlands
State/province [13] 0 0
Rotterdam
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Málaga
Country [17] 0 0
Spain
State/province [17] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01045304
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01045304