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

August 16, 2022 updated by: Stemline Therapeutics, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Radius Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elacestrant

Part 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
Drug: Elacestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicities (DLT)
Time Frame: The first 28 days of treatment.
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.
The first 28 days of treatment.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stemline Therapeutics, Inc.

Investigators

  • Study Director: Sr. Director, Clinical Operations, Radius Pharmaceticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAD1901-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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