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

NCT03088527 | Completed Phase 1 FDA Drug

• 1 other identifier: RAD140-01-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Outcome Measures

Primary Outcomes (3)

• Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment

  Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment

  First 28 days of treatment

• Number of adverse events related to study treatment

  Number of adverse events related to study treatment

  Up to 30 days after end of treatment

• Number participants with dose interruptions and dose adjustments

  Number participants with dose interruptions and dose adjustments

  Up to 30 days after end of treatment

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  Day 1 and 15

• Time to maximum plasma concentration (Tmax)

  Day 1 and 15

• Area under the plasma concentration versus time curve (AUC)

  Day 1 and Day 15

• Tumor response

  Screening and every 8 weeks for up to 12 months of treatment

Study Arms (1)

RAD140 Part A and Part B

EXPERIMENTAL

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

Interventions

RAD140 DRUG

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

RAD140 Part A and Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stemline Therapeutics, Inc.: lead

Study Sites (5)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Cancer Center Protocol Office

Boston, Massachusetts, 02114, United States

Location

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

RAD140

Study Officials

• Sr. Director, Clinical Operations

  Radius

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 23, 2017
• Study Start: October 23, 2017
• Primary Completion: August 28, 2020
• Study Completion: September 24, 2020
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)