Spots Global Cancer Trial Database for Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients
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Trial Identification
Brief Title: Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients
Official Title: A First-in-Human Study to Determine the Safety, Pharmacokinetics and Efficacy of KPG-121 When Administered With Enzalutamide, Abiraterone, or Apalutamide in Subjects With Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT03569280
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.
Detailed Description: This Phase 1 study will comprise two parts: Part 1 will be a 3+3 dose escalation design to characterize the MTD and a RP2D, Part 2 will be an expansion cohort at RP2D.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists, Port Jefferson Station, New York, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Contact Details
Name: Yao Wang
Affiliation: Kangpu Biopharmaceuticals, Ltd.
Role: STUDY_DIRECTOR
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