Clinical Trials /

Evaluation of Orally Administered SAR439859 in Japanese Postmenopausal Patients With Advanced Breast Cancer

NCT03816839

Description:

Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Secondary Objectives: - To characterize the overall safety profile of SAR439859 administered as monotherapy. - To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy. - To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Evaluation of Orally Administered SAR439859 in Japanese Postmenopausal Patients With Advanced Breast Cancer
  • Official Title: A Phase 1 Study for the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy in Japanese Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: TED15954
  • SECONDARY ID: U1111-1217-2758
  • NCT ID: NCT03816839

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
SAR439859SAR439859

Purpose

Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Secondary Objectives: - To characterize the overall safety profile of SAR439859 administered as monotherapy. - To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy. - To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

Detailed Description

      The duration of the study for an individual participant will include a period to assess
      eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1
      cycle (28 days) of study treatment, and an End of Treatment (EOT) visit at least 30 days (or
      until the participant receives another anticancer therapy, whichever is earlier) following
      the last administration of study treatment. Study treatment may continue until precluded by
      unacceptable toxicity, disease progression, or upon participant's request.
    

Trial Arms

NameTypeDescriptionInterventions
SAR439859ExperimentalSAR439859, administered orally once daily as monotherapy in fasted or fed state
  • SAR439859

Eligibility Criteria

        Inclusion criteria:

          -  Participants must be postmenopausal women.

          -  Breast adenocarcinoma patients with locally advanced not amenable to radiation or
             surgery, inoperable and/or metastatic disease.

          -  Either the primary or any metastatic site must be positive for estrogen receptor (ER)
             (>1% staining by immunohistochemistry).

          -  Either the primary tumor or any metastatic site must be human epidermal growth factor
             receptor 2 non-overexpressing.

          -  Patients with at least 6 months of prior endocrine therapy.

        Exclusion criteria:

          -  Eastern Cooperative Oncology Group Performance Status (ECOG) ≥2.

          -  Significant concomitant illness that would adversely affect participation in the
             study.

          -  Patients with a life expectancy less than 3 months.

          -  Patient not suitable for participation, whatever the reason.

          -  Major surgery within 4 weeks prior to first study treatment administration.

          -  Treatment with strong and moderate cytochrome P450 3A inhibitors/inducers.

          -  Patients with known endometrial disorders, uterine bleeding or ovarian cysts.

          -  Treatment with anticancer less than 2 weeks before first study treatment.

          -  Prior treatment with selective estrogen receptor down (SERD)-regulator (except
             fulvestrant).

          -  Inadequate hematological function.

          -  Inadequate renal function with serum creatinine ≥1.5 x upper limit of normal (ULN).

          -  Liver function: aspartate aminotransferase >3 x ULN, or alanine aminotransferase >3 x
             ULN. Total bilirubin >1.5 x ULN.

          -  Non-resolution of any prior treatment related toxicity to <Grade 2, except for
             alopecia

        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:20 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
Time Frame:Day 1 to Day 28
Safety Issue:
Description:Incidence rate of study treatment-related DLTs at Cycle 1

Secondary Outcome Measures

Measure:Safety: Adverse Events (AEs)
Time Frame:Up to 30 days after administration of study treatment
Safety Issue:
Description:Number of adverse events related to study therapy
Measure:Assessment of Pharmacokinetic parameter of SAR439859: tlag
Time Frame:Day 1 and Day 22 of Cycle 1 (28 days)
Safety Issue:
Description:Lag time, interval between administration time and the sampling time preceding the first concentration above the lower limit of quantification
Measure:Assessment of Pharmacokinetic parameter of SAR439859: tmax
Time Frame:Day 1 and Day 22 of Cycle 1 (28 days)
Safety Issue:
Description:First time to reach Cmax
Measure:Assessment of Pharmacokinetic parameter of SAR439859: Cmax
Time Frame:Day 1 and Day 22 of Cycle 1 (28 days)
Safety Issue:
Description:Maximum concentration observed
Measure:Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24
Time Frame:Day 1 and Day 22 of Cycle 1 (28 days)
Safety Issue:
Description:Area under the plasma concentration versus time curve over the dosing interval (24 hours)
Measure:Assessment of Pharmacokinetic parameter of SAR439859: Ctrough
Time Frame:Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2 (28 days)
Safety Issue:
Description:Plasma concentration observed just before treatment administration during repeated dosing
Measure:Assessment of antitumor activity: Objective response rate (ORR)
Time Frame:64 weeks
Safety Issue:
Description:Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measure:Assessment of antitumor activity: Clinical benefit rate (CBR)
Time Frame:64 weeks
Safety Issue:
Description:Clinical benefit rate is (CR [complete response] +PR [partial response] +SD [stable disease] ≥24 weeks) as per RECIST 1.1
Measure:Assessment of antitumor activity: Duration of response
Time Frame:64 weeks
Safety Issue:
Description:Response duration defined as the time from initial response to the first documented tumor progression
Measure:Assessment of antitumor activity: Non-progression rate
Time Frame:24 weeks
Safety Issue:
Description:Non-progression rate at 24 weeks (percentage of participants without progression at 24 weeks)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sanofi

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