Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
RAD140-01-001
- NCT ID:
NCT03088527
Conditions
- Hormone Receptor Positive Malignant Neoplasm of Breast
Interventions
Drug | Synonyms | Arms |
---|
RAD140 | | RAD140 Part A and Part B |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment |
Time Frame: | First 28 days of treatment |
Safety Issue: | |
Description: | Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment |
Secondary Outcome Measures
Measure: | Maximum plasma concentration (Cmax) |
Time Frame: | Day 1 and 15 |
Safety Issue: | |
Description: | Maximum plasma concentration (Cmax) |
Measure: | Time to maximum plasma concentration (Tmax) |
Time Frame: | Day 1 and 15 |
Safety Issue: | |
Description: | Time to maximum plasma concentration (Tmax) |
Measure: | Area under the plasma concentration versus time curve (AUC) |
Time Frame: | Day 1 and Day 15 |
Safety Issue: | |
Description: | Area under the plasma concentration versus time curve (AUC) |
Measure: | Tumor response |
Time Frame: | Screening and every 8 weeks for up to 12 months of treatment |
Safety Issue: | |
Description: | Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Radius Pharmaceuticals, Inc. |
Last Updated
October 19, 2020