Spots Global Cancer Trial Database for A Study of FT-7051 in Men With MCRPC
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Trial Identification
Brief Title: A Study of FT-7051 in Men With MCRPC
Official Title: A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT04575766
Interventions
Study Description
Brief Summary: This is a Phase 1, open-label study that will evaluate the safety and tolerability of FT-7051 and determine the recommended Phase 2 dose (RP2D) as well as pharmacokinetics (PK), preliminary anti-tumor activity, and pharmacodynamics (PD) of FT-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy. The starting dose, 25 mg once daily (QD), of FT-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
HonorHealth, Scottsdale, Arizona, United States
University of Colorado Health, Aurora, Colorado, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States
University of Maryland, Greenebaum Cancer Center, Baltimore, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Icahn School of Medicine at Mt. Sinai, New York, New York, United States
Duke University Health System, Durham, North Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Contact Details
Name: Emma Barrett, MD
Affiliation: Novo Nordisk A/S
Role: STUDY_DIRECTOR
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