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

NCT01045304 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2014-01-14

No results posted yet for this study

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).

Conditions

  • Breast Cancer, Metastatic

Interventions

DRUG

Iniparib

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Gemcitabine

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Carboplatin

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-03-31
Completion
2012-11-30

Countries

  • Australia
  • Belgium
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01045304 on ClinicalTrials.gov