Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer
- Conditions
- 10006291breast cancermamma carcinoma
- Registration Number
- NL-OMON46882
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
-Measurable Metastatic triple negative breast cancer (TNBC).
-Patients with CA6-positive disease.
-Patients received at least 1 prior chemotherapy regimen but no more than 3 for advanced/metastatic disease.;-Prior anticancer therapy must have contained anthracycline (eg, doxorubicin), if not contraindicated, and a taxane (eg, docetaxel, paclitaxel) in an adjuvant/neo-adjuvant or metastatic setting.
-Eastern Cooperative Oncology Group (ECOG) performance status *2.
-Patient less than 18 years old.
-Pregnant or breast-feeding women.
-Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of study drug.
-Wash out period of less than 3 weeks or 5 half-lives from previous antitumor chemotherapy, immunotherapy, or any investigational treatment.
-History of brain metastasis, spinal cord compression or carcinomatous meningitis, or new evidence of brain leptomeningeal disease.
-Prior treatment with eribulin as last prior therapy or prior maytansinoid treatments.
-Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
-Poor bone marrow reserve and/or poor organ function.
-Symptomatic peripheral neuropathy Grade *2.
-Previous history of chronic corneal diseases or unresolved acute nonrecurrent corneal conditions.
-Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
-Medical conditions requiring concomitant administration of strong CYP3A4 inhibitors, unless it can be discontinued at least 2 weeks before 1st administration of SAR566658.
-Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To select in the first part the SAR566658 dose based on Objective Response Rate<br /><br>(ORR) and<br /><br>safety of 2 dose levels and to demonstrate in the second part the efficacy of<br /><br>the selected dose<br /><br>based on ORR.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-To assess:<br /><br>-Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free<br /><br>Survival (PFS),<br /><br>and Time To Progression (TTP);<br /><br>-The impact of ocular primary prophylaxis on the incidence of keratopathies</p><br>