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Brief Title: A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
Official Title: A Multicenter Study Evaluating Safety and Efficacy of TAR-200 in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
Study ID: NCT03404791
Brief Summary: The purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of TAR-200 for 21 days per dosing cycle in the induction period.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
North Georgia Urology Center, Dalton, Georgia, United States
Chesapeake Urology Research Associates, Hanover, Maryland, United States
Michigan Institute of Urology, Troy, Michigan, United States
University of Rochester, Rochester, New York, United States
Urology Associates, PC, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
North Austin Urology, Austin, Texas, United States
Urology of Virginia, PLCC, Virginia Beach, Virginia, United States
Fundacion Puigvert, Barcelona, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Inst. Valenciano de Oncologia, Valencia, , Spain
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR