Trial record 1 of 1 for:
A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
This study is not yet open for participant recruitment.
Verified March 2017 by Radius Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.
First received: February 28, 2017
Last updated: March 16, 2017
Last verified: March 2017
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.
Hormone Receptor Positive Malignant Neoplasm of Breast
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Primary Outcome Measures:
- Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment [ Time Frame: First 28 days of treatment ]
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
- Number of adverse events related to study treatment [ Time Frame: Up to 30 days after end of treatment ]
Number of adverse events related to study treatment
- Number participants with dose interruptions and dose adjustments [ Time Frame: Up to 30 days after end of treatment ]
Number participants with dose interruptions and dose adjustments
Secondary Outcome Measures:
- Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and 15 ]
Maximum plasma concentration (Cmax)
- Time to maximum plasma concentration (Tmax) [ Time Frame: Day 1 and 15 ]
Time to maximum plasma concentration (Tmax)
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1 and Day 15 ]
Area under the plasma concentration versus time curve (AUC)
- Tumor response [ Time Frame: 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.
| Estimated Enrollment:
| Anticipated Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2020 (Final data collection date for primary outcome measure)
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.
RAD140 will be supplied as formulated drug-in-capsules for oral administration.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
||Radius Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 28, 2017
||March 16, 2017
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
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Hormones, Hormone Substitutes, and Hormone Antagonists
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