Clinical trial NCT03088527: Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
Official title: A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast
Lead sponsor: Stemline Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
timeFrame: First 28 days of treatment
measure: Number of adverse events related to study treatment
timeFrame: Up to 30 days after end of treatment
measure: Number participants with dose interruptions and dose adjustments
timeFrame: Up to 30 days after end of treatment
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 1 and 15
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Day 1 and 15
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Day 1 and Day 15
measure: Tumor response
timeFrame: Screening and every 8 weeks for up to 12 months of treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Boston
country: United States
facility: Cancer Center Protocol Office
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: Radius
name: Sr. Director, Clinical Operations
role: STUDY_DIRECTOR
References: