Spots Global Cancer Trial Database for TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer
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Trial Identification
Brief Title: TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer
Official Title: Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC
Study ID: NCT04887506
Study Description
Brief Summary: The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.
Detailed Description: This is a Phase 3 randomized, open-label study to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) in patients with high-risk metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC). Randomization was stratified by prostate cancer population (CSPC vs CRPC) and baseline testosterone (\<10 vs ≥ 10 ng/dL). Patients were treated for 84 days and randomized into one of two groups in a 1:1 ratio: * TAVT-45: Administered twice daily as 1 x sachet containing TAVT-45 (250 mg abiraterone acetate), reconstituted in water or specified fruit juice (orange juice), + Prednisone (5 mg once or twice daily, depending on prostate cancer population) * R-AA: Administered once daily as (2 x 500 mg Zytiga tablets) + Prednisone (5 mg once or twice daily, depending on prostate cancer population)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Research Site, Homewood, Alabama, United States
Research Site, Tucson, Arizona, United States
Research Site, Little Rock, Arkansas, United States
Research Site, Los Angeles, California, United States
Research Site, San Bernardino, California, United States
Research Site, Denver, Colorado, United States
Research Site, Bradenton, Florida, United States
Research Site, Meridian, Idaho, United States
Research Site, Jeffersonville, Indiana, United States
Research Site, Annapolis, Maryland, United States
Research Site, Troy, Michigan, United States
Research Site, New York, New York, United States
Research Site, Virginia Beach, Virginia, United States
Research Site, Suresnes, Hauts-de-Seine, France
Research Site, Brest, , France
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Warszawa, Masovia, Poland
Research Site, Bydgoszcz, , Poland
Research Site, Lublin, , Poland
Research Site, Piaseczno, , Poland
Research Site, Warszawa, , Poland
Research Site, Ponce, , Puerto Rico
Research Site, Madrid, Arturo Soria, 270, Spain
Research Site, Madrid, Av. Reyes Católicos 2, Spain
Research Site, Manresa, Barcelona, Spain
Research Site, Madrid, Calle De Oña 10, Spain
Research Site, Barcelona, Sabadell, Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Lleida, , Spain
Research Site, Madrid, , Spain
Research Site, Sevilla, , Spain
Research Site, Gothenburg, , Sweden
Research Site, Västerås, , Sweden
Research Site, Torquay, Devon, United Kingdom
Research Site, Cheltenham, Gloucestershire, United Kingdom
Research Site, Hampstead, London, United Kingdom
Research Site, Glasgow, Scotland, United Kingdom
Research Site, Guildford, Surrey, United Kingdom
Research Site, London, , United Kingdom
Contact Details
Name: Andreas Maetzel, MD, PhD
Affiliation: Tavanta Therapeutics inc.
Role: STUDY_CHAIR
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