Clinical Trials /

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

NCT03088527

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
  • Official Title: A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: RAD140-01-001
  • NCT ID: NCT03088527

Conditions

  • Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

DrugSynonymsArms
RAD140RAD140

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.

Trial Arms

NameTypeDescriptionInterventions
RAD140ExperimentalPart 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.
  • RAD140

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Time Frame:First 28 days of treatment
Safety Issue:
Description:Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment

Secondary Outcome Measures

Measure:Maximum plasma concentration (Cmax)
Time Frame:Day 1 and 15
Safety Issue:
Description:Maximum plasma concentration (Cmax)
Measure:Time to maximum plasma concentration (Tmax)
Time Frame:Day 1 and 15
Safety Issue:
Description:Time to maximum plasma concentration (Tmax)
Measure:Area under the plasma concentration versus time curve (AUC)
Time Frame:Day 1 and Day 15
Safety Issue:
Description:Area under the plasma concentration versus time curve (AUC)
Measure:Tumor response
Time Frame:Screening and every 8 weeks for up to 12 months of treatment
Safety Issue:
Description:Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Radius Pharmaceuticals, Inc.

Last Updated

February 12, 2018