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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Radius Health, Inc.
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT02338349
First received: December 31, 2014
Last updated: March 1, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of RAD1901 in patients with advanced ER+, HER2-negative breast cancer.

Condition Intervention Phase
Advanced ER+, HER2-Negative Breast Cancer
Drug: RAD1901
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Open-Label, Two-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • Dose Limiting Toxicities (DLT) [ Time Frame: The first 28 days of treatment. ] [ Designated as safety issue: Yes ]
    To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of RAD1901, the incidence of Dose Limiting toxicities (DLTs) will be assessed during the first 28 days.


Secondary Outcome Measures:
  • Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values [ Time Frame: Up to 30 days after the end of treatment. ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values.


Other Outcome Measures:
  • Plasma concentrations of RAD1901 will be assessed at predefined intervals. [ Time Frame: Every 28 days for up to 12 months of treatment. ] [ Designated as safety issue: No ]
  • Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines. [ Time Frame: Every 8 weeks until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD1901

Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD1901.

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.

Drug: RAD1901

Detailed Description:

The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RAD1901 in patients with advanced ER+HER2-negative breast cancer.

The secondary objectives of this study are:

  • To assess the safety and tolerability of RAD1901
  • To evaluate the pharmacokinetics (PK) of RAD1901
  • To evaluate the preliminary anti-tumor effect of RAD1901
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy

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. Fulvestrant therapy less than 90 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02338349

Contacts
Contact: Janine McDermott (617) 551-4078 jmcdermott@radiuspharm.com

Locations
United States, Massachusetts
Radius Health, Inc. Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Study Director         
Sponsors and Collaborators
Radius Health, Inc.
  More Information

Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT02338349     History of Changes
Other Study ID Numbers: RAD1901-005 
Study First Received: December 31, 2014
Last Updated: March 1, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 29, 2016