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

Completed · Phase 1

Conditions studied: Urinary Bladder Neoplasms

In brief

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.

Key facts

Study ID

NCT03404791

Run by

Janssen Research & Development, LLC

People needed

35

Starts

2017-11-20

Expected to finish

2022-09-15

Last updated by the study team

2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder
• Participant must have been as fully resected as possible per the physician's judgment
• Participants must be deemed unfit for RC due to comorbid conditions with a risk of mortality
• Participants must refuse or be deemed ineligible for cisplatin-based chemotherapy
• Participant must refuse or not be eligible for radiotherapy

You may not qualify if…

• Other active malignancies
• Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-200
• Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed)
• Evidence of bladder perforation during diagnostic cystoscopy
• Concurrent clinically significant infections as determined by the treating Investigator

Where it is running

• 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
• Fund. Puigvert — Barcelona, Spain
• Hosp. Univ. 12 de Octubre — Madrid, Spain
• Inst. Valenciano de Oncologia — Valencia, Spain

Full record on ClinicalTrials.gov

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