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Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03088527
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

Brief Summary:
The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Malignant Neoplasm of Breast Drug: RAD140 Phase 1

Detailed Description:
This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RAD140 Part A and Part B

Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD140.

Part B, Safety Expansion: Once the maximum tolerated dose (MTD) has been identified and/or a recommended dose escalation (RDE) has been determined, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary clinical activity of the recommended dose.

Drug: RAD140
RAD140 will be supplied as formulated drug-in-capsules for oral administration.




Primary Outcome Measures :
  1. Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment [ Time Frame: First 28 days of treatment ]
    Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment

  2. Number of adverse events related to study treatment [ Time Frame: Up to 30 days after end of treatment ]
    Number of adverse events related to study treatment

  3. Number participants with dose interruptions and dose adjustments [ Time Frame: Up to 30 days after end of treatment ]
    Number participants with dose interruptions and dose adjustments


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and 15 ]
    Maximum plasma concentration (Cmax)

  2. Time to maximum plasma concentration (Tmax) [ Time Frame: Day 1 and 15 ]
    Time to maximum plasma concentration (Tmax)

  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1 and Day 15 ]
    Area under the plasma concentration versus time curve (AUC)

  4. Tumor response [ Time Frame: Screening and every 8 weeks for up to 12 months of treatment ]
    Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.



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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:

  • Progressive metastatic or locally advanced or metastatic breast cancer.
  • Clinically confirmed as postmenopausal.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.

Key Exclusion Criteria:

  • HER2 positive patients by local laboratory testing.
  • Triple negative breast cancer.
  • Any chemotherapy within the 28 days prior to the first dose of study drug.
  • Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
  • Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
  • Fulvestrant within 30 days prior to first dose of study drug.
  • Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.
  • Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.
  • Known history of human immunodeficiency virus infection (HIV) or hepatitis C or active hepatitis B infection, unless the patient was diagnosed >10 years prior to enrollment and no evidence of active liver disease.
  • Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
  • Untreated or uncontrolled brain metastasis.
  • Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.
  • Pregnant and nursing females.

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): NCT03088527


Contacts
Contact: Director, Clinical Operations 617-551-4005 clinopsinfo@radiuspharm.com
Contact: Kathryn Davis (617) 551-4029 kdavis@radiuspharm.com

Locations
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Nicole Sinclair, RN         
Principal Investigator: Patricia LoRusso, MD         
United States, Massachusetts
Cancer Center Protocol Office Recruiting
Boston, Massachusetts, United States, 02114
Contact: Neelima Vidula, MD         
Principal Investigator: Neelima Vidula, MD         
United States, Michigan
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Michele Lowe, RN         
Principal Investigator: Amy Weise, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cynthia Ma, MD         
Principal Investigator: Cynthia MA, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Megan Roberts, RN         
Principal Investigator: Erika Hamilton, MD         
Sponsors and Collaborators
Radius Pharmaceuticals, Inc.
Investigators
Study Director: Sr. Director, Clinical Operations Radius

Responsible Party: Radius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03088527     History of Changes
Other Study ID Numbers: RAD140-01-001
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases