Clinical Trial - NCT03088527

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

Recruiting

Sponsor: Radius Pharmaceuticals, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03088527

Protocol Info

Short Description: A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Long Description: A Phase 1, First-In-Human, Multi-Part Study of RAD140 in Postmenopausal Women Hormone Receptor Positive Breast Cancer
MGH Status: Open
Sponsor: Radius Health
Disease Program: Breast

Next Steps


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Purpose

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 Title Intervention Phase
Hormone Receptor Positive Malignant Neoplasm of Breast RAD140 Phase 1
Study Type Interventional
Official Title A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Primary Outcome Measures

Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment [Time Frame: First 28 days of treatment] [Designated as safety issue: ]

Number of adverse events related to study treatment [Time Frame: Up to 30 days after end of treatment] [Designated as safety issue: ]

Number participants with dose interruptions and dose adjustments [Time Frame: Up to 30 days after end of treatment] [Designated as safety issue: ]


Secondary Outcome Measures

Maximum plasma concentration (Cmax) [Time Frame: Day 1 and 15] [Designated as safety issue: ]

Time to maximum plasma concentration (Tmax) [Time Frame: Day 1 and 15] [Designated as safety issue: ]

Area under the plasma concentration versus time curve (AUC) [Time Frame: Day 1 and Day 15] [Designated as safety issue: ]

Tumor response [Time Frame: Screening and every 8 weeks for up to 12 months of treatment] [Designated as safety issue: ]

Estimated Enrollment: 40
Study Start Date: October 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: July 2020
Arms Assigned Interventions

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Female

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03088527

Locations

  • United States, Connecticut
    • Yale Cancer Center New Haven, Connecticut, United States, 06510
  • United States, Massachusetts
    • Cancer Center Protocol Office Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • Barbara Ann Karmanos Cancer Center Detroit, Michigan, United States, 48201
  • United States, Missouri
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
  • United States, Tennessee
    • Sarah Cannon Research Institute Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Radius Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03088527
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Neoplasms

Breast Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019