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

Stemline Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast

Treatments: Drug: RAD140

Study type: Interventional

Funder types: Other

Identifiers

NCT03088527

RAD140-01-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RAD140 Part A and Part B

Experimental group

Description:

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.

Treatment:

Drug: RAD140