Clinical Trials /

A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

NCT02338349

Description:

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
  • Official Title: A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: RAD1901-005
  • NCT ID: NCT02338349

Conditions

  • Advanced ER+, HER2-Negative Breast Cancer

Interventions

DrugSynonymsArms
ElacestrantElacestrant

Purpose

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.

Detailed Description

      The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended
      Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer.

      The secondary objectives of this study are:

        -  To assess the safety and tolerability of elacestrant

        -  To evaluate the pharmacokinetics (PK) of elacestrant

        -  To evaluate the preliminary anti-tumor effect of elacestrant
    

Trial Arms

NameTypeDescriptionInterventions
ElacestrantExperimentalPart A, Dose Escalation: Patients will be assigned sequentially to escalating doses of elacestrant. Part B, Safety Expansion: Once the MTD has been identified and/or a RP2D has been selected, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary efficacy of the RP2D. Part C, Tablet Introduction: A cohort of patients will be enrolled to evaluate the safety, tolerability, and PK of a tablet dosage form at 400 mg QD. Part D, Dose Expansion: A cohort of patients will be enrolled to evaluate the safety, tolerability, PK and preliminary anti-tumor effect of elacestrant in tablet dosage form at 400 mg QD PO in a group of patients with a more homogeneous prior treatment history
  • Elacestrant

Eligibility Criteria

        Key Inclusion Criteria:

          1. Patients must be post-menopausal women, as defined in the protocol

          2. 18 years or older

          3. Patients with histological or cytological proven diagnosis of adenocarcinoma of the
             breast with evidence of either locally advanced, inoperable and/or metastatic disease

          4. Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic
             regimens and at least 6 months of prior endocrine therapy

          5. Part D: Patients may have received up to 1 previous line of chemotherapy and must have
             previously received 2 or more lines of endocrine therapy for advanced/metastatic
             breast cancer as a single agent or in combination. Patients must have received
             fulvestrant as one of the previous lines of endocrine therapy and have had documented
             progression while on, or within 1 month after the end of, fulvestrant therapy for
             advanced/metastatic breast cancer. Patients must have received prior treatment with a
             CDK4/6 inhibitor

        Note: This list is not complete. Further inclusion criteria is provided in the protocol
        synopsis.

        Key Exclusion Criteria:

          1. Prior anticancer or investigational drug treatment within the following windows:

               1. Tamoxifen therapy less than 14 days before first dose of study treatment

               2. Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study
                  treatment. Part D: Fulvestrant therapy less than 42 days before first dose of
                  study treatment

               3. Any other anti-cancer endocrine therapy less than 14 days before first dose of
                  study treatment

               4. Any chemotherapy less than 28 days before first dose of study

               5. Any investigational drug therapy less than 28 days or 3 half-lives (whichever is
                  longer) prior to first dose of study treatment

          2. Patients with untreated or symptomatic central nervous system (CNS) metastases

          3. Patients with endometrial disorders, including evidence of endometrial hyperplasia,
             dysfunctional uterine bleeding or cysts

        Note: This list is not complete. Further exclusion criteria is provided in the protocol
        synopsis.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities (DLT)
Time Frame:The first 28 days of treatment.
Safety Issue:
Description:To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.

Secondary Outcome Measures

Measure:Safety and Tolerability of Elacestrant (RAD1901)
Time Frame:Up to 30 days after the end of treatment.
Safety Issue:
Description:Safety and tolerability will be assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values.
Measure:Pharmacokinetics of Elacestrant (RAD1901)
Time Frame:Every 28 days
Safety Issue:
Description:Plasma concentrations of RAD1901 will be assessed at predefined intervals
Measure:Anti-Tumor Effect of Elacestrant (RAD1901)
Time Frame:Every 8 weeks
Safety Issue:
Description:Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Radius Pharmaceuticals, Inc.

Last Updated

January 19, 2018