Hormone Receptor Positive Malignant Neoplasm of Breast
Conditions
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.
Interventions
DRUGRAD140
RAD140 will be supplied as formulated drug-in-capsules for oral administration.
Sponsors
Stemline Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events related to study treatment | Up to 30 days after end of treatment | Number of adverse events related to study treatment |
| Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment | First 28 days of treatment | Incidence rate of dose-limiting toxicities (DLTs) RAD140 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | Day 1 and 15 | Maximum plasma concentration (Cmax) |
| 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. |
| Time to maximum plasma concentration (Tmax) | Day 1 and 15 | Time to maximum plasma concentration (Tmax) |
| Area under the plasma concentration versus time curve (AUC) | Day 1 and Day 15 | Area under the plasma concentration versus time curve (AUC) |
Countries
United States
Outcome results
None listed