Cancer MedDRA version: 19.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: SAR566658
Product Code: SAR566658
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not applicable
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS), and Time To Progression (TTP) ; - The PK profile of SAR566658 - The impact of ocular primary prophylaxis on the incidence of keratopathies ; - The potential immunogenicity of SAR566658 ; - The relationship between CA6 expression level in the tumor, and circulating CA6 in blood at baseline, and efficacy outcomes - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Disease control rate 2/ Duration of response - time 3/ Progression free survival - time 4/ Time to progression 5/ Number of keratopathies 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 3-4 : at 2 years 5 : Up to 30 days after the 3-week treatment cycle(s) (until 30 days after last treatment administration) 6 : Up to 60 days after the 3-week treatment cycle(s) (until 60 days after last treatment administration) | — |
Countries
Belgium, Czech Republic, France, Netherlands, Spain, United States
Contacts
Public ContactMaya Feijen
sanofi-aventis The Netherlands B.V.
Outcome results
None listed