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

2014-07-23 21:11:11 | BioPortfolio

Summary

Primary Objective:

- To assess the objective response rate (ORR) of SAR240550 administered as a 60min intravenous 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 SAR240550

- To evaluate the pharmacokinetic (PK) profile of SAR240550 in both arms (optional)

- To assess biological and pharmacogenomic parameters on tumor tissue during study treatment period in both arms (optional)

Description

The duration of the study for a patient will include 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In case of discontinuation of study treatment, the patient will be considered as withdrawn from study treatment, and will be followed as planned for at least 30 days after the last administration of study treatment for safety purpose.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 study cut-off date whatever comes first. After the study cut-off date for primary analysis, the patient will be followed-up every 12 weeks (3 months) for efficacy until disease progression or end of study or for one year.

The patients who benefit from the study treatment can continue until disease progression, toxicity or willingness to stop.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer, Metastatic

Intervention

SAR240550 (BSI-201), Gemcitabine, Carboplatin

Location

Sanofi-Aventis Investigational Site Number 036002
Parkville
Australia
3052

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:11-0400

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