Clinical Trials /

Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer

NCT02984683

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
SAR566658 (ACT14884)SAR566658 (Part 2)

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

NameTypeDescriptionInterventions
SAR566658 (Part 1)ExperimentalSAR566658 will be given as Dose 1 (cohort 1) and Dose 2 (cohort 2) at Day 1 and Day 8 every 3 weeks intravenously
  • SAR566658 (ACT14884)
SAR566658 (Part 2)ExperimentalSAR566658 (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
  • SAR566658 (ACT14884)

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:Recruiting
Lead Sponsor:Sanofi

Trial Keywords

    Last Updated

    April 7, 2017