Description:
Primary 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 Objectives:
- To assess:
- Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS),
and Time To Progression (TTP)
- The impact of ocular primary prophylaxis on the incidence of keratopathies;
- The potential immunogenicity of SAR566658
- To evaluate the global safety profile
Title
- Brief Title: Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
- Official Title: Open-label Phase 2 Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
ACT14884
- SECONDARY ID:
2016-001962-27
- SECONDARY ID:
U1111-1182-7044
- NCT ID:
NCT02984683
Conditions
- Triple Negative Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
SAR566658 (ACT14884) | | SAR566658 (Part 1) |
Purpose
Primary 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 Objectives:
- To assess:
- Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS),
and Time To Progression (TTP)
- The impact of ocular primary prophylaxis on the incidence of keratopathies;
- The potential immunogenicity of SAR566658
- To evaluate the global safety profile
Detailed Description
The duration of the study for 1 patient will include a screening period of up to 21 days
prior to first study drug administration, 3-week treatment cycle(s) (until 30 days after last
SAR566658 administration), and a follow-up period. Each patient will be treated until
radiological disease progression, unacceptable toxicity, or patient's refusal of further
study treatment.
Trial Arms
Name | Type | Description | Interventions |
---|
SAR566658 (Part 1) | Experimental | SAR566658 will be given as Dose 1 (cohort 1) and Dose 2 (cohort 2) at Day 1 and Day 8 every 3 weeks intravenously | |
SAR566658 (Part 2) | Experimental | SAR566658 (Part 2) - SAR566658 will be given as Dose 1 or Dose 2 (depending on dose level selected from part 1) at Day 1 and Day 8 every 3 weeks intravenously | |
Eligibility 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.
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.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Disease control rate |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response - time |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival - time |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Time to progression |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Number of keratopathies |
Time Frame: | Up to 30 days after the 3-week treatment cycle(s) (until 30 days after last treatment administration) |
Safety Issue: | |
Description: | |
Measure: | Incidence of positive patients for antidrug antibodies as a measure of SAR566658 immunogenicity |
Time Frame: | Up to 60 days after the 3-week treatment cycle(s) (until 60 days after last treatment administration) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Sanofi |
Last Updated
August 16, 2019