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

Trial Status: Complete

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.

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.

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.

Connecticut

New Haven
Yale University
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Radius Pharmaceuticals, Inc.

  • Primary ID RAD140-01-001
  • Secondary IDs NCI-2017-01503
  • Clinicaltrials.gov ID NCT03088527