Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
- Conditions
- Hormone Receptor Positive Malignant Neoplasm of Breast
- Interventions
- Registration Number
- NCT03088527
- Lead Sponsor
- Stemline Therapeutics, Inc.
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RAD140 Part A and Part B RAD140 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.
- Primary Outcome Measures
Name Time Method Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment First 28 days of treatment Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Number of adverse events related to study treatment Up to 30 days after end of treatment Number of adverse events related to study treatment
Number participants with dose interruptions and dose adjustments Up to 30 days after end of treatment Number participants with dose interruptions and dose adjustments
- Secondary Outcome Measures
Name Time Method Time to maximum plasma concentration (Tmax) Day 1 and 15 Time to maximum plasma concentration (Tmax)
Maximum plasma concentration (Cmax) Day 1 and 15 Maximum plasma concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) Day 1 and Day 15 Area under the plasma concentration versus time curve (AUC)
Tumor response Screening and every 8 weeks for up to 12 months of treatment Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.
Trial Locations
- Locations (5)
Cancer Center Protocol Office
🇺🇸Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States