Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03088527|
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : August 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Hormone Receptor Positive Malignant Neoplasm of Breast||Drug: RAD140||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer|
|Actual Study Start Date :||October 23, 2017|
|Actual Primary Completion Date :||August 28, 2020|
|Actual Study Completion Date :||September 24, 2020|
Experimental: RAD140 Part A and Part B
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.
- 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
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088527
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06510|
|United States, Massachusetts|
|Cancer Center Protocol Office|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Center|
|Detroit, Michigan, United States, 48201|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Sr. Director, Clinical Operations||Radius|
|Responsible Party:||Stemline Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||March 23, 2017 Key Record Dates|
|Last Update Posted:||August 18, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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