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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

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ClinicalTrials.gov Identifier: NCT02338349
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced ER+, HER2-Negative Breast Cancer Drug: Elacestrant Phase 1

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  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Pharmacokinetics of Elacestrant (RAD1901) [ Time Frame: Every 28 days ]
    Plasma concentrations of RAD1901 will be assessed at predefined intervals

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338349


Locations
United States, Massachusetts
Radius Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Radius Pharmaceuticals, Inc.
Investigators
Study Director: Sr. Director, Clinical Operations Radius Pharmaceticals, Inc

Responsible Party: Radius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02338349     History of Changes
Other Study ID Numbers: RAD1901-005
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs