Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast Cancer
- Conditions
- CancerMedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001962-27-BE
- Lead Sponsor
- Sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
-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 (other than totally resected or previously irradiated and nonprogressive/relapsed), 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 (DM1 or DM4 antibody-drug conjugates [ADCs]).
-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 (even if asymptomatic) 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected dose based on ORR.;Secondary Objective: - To assess:<br> - Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS), and Time To Progression (TTP) ;<br> - The PK profile of SAR566658<br> - The impact of ocular primary prophylaxis on the incidence of keratopathies ;<br> - The potential immunogenicity of SAR566658 ;<br> - The relationship between CA6 expression level in the tumor, and circulating CA6 in<br>blood at baseline, and efficacy outcomes<br><br>- To evaluate the global safety profile.;Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: evaluation at 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1/ Disease control rate<br>2/ Duration of response - time<br>3/ Progression free survival - time<br>4/ Time to progression<br>5/ Number of keratopathies<br>6/ Incidence of positive patients for antidrug antibodies as a measure of SAR566658 immunogenicity;Timepoint(s) of evaluation of this end point: 1-2 : at 18 months<br>3-4 : at 2 years<br>5 : Up to 30 days after the 3-week treatment cycle(s) (until 30 days after last treatment administration)<br>6 : Up to 60 days after the 3-week treatment cycle(s) (until 60 days after last treatment administration)