Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:October 23, 2017
End Date:December 2020
Contact:Director, Clinical Operations
Email:clinopsinfo@radiuspharm.com
Phone:617-551-4005

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A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

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.

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.

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.
We found this trial at
5
sites
Detroit, Michigan 48201
Principal Investigator: Amy Weise, MD
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Detroit, MI
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55 Fruit Street
Boston, Massachusetts 02114
Principal Investigator: Neelima Vidula, MD
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Boston, MA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Erika Hamilton, MD
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Patricia LoRusso, MD
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Cynthia MA, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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