Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT03404791

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 12 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
North Georgia Urology Center
Dalton Georgia, 30720, United States
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States
Michigan Institute of Urology
Troy Michigan, 48084, United States
University of Rochester
Rochester New York, 14642, United States
Urology Associates, PC
Nashville Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
North Austin Urology
Austin Texas, 78750, United States
Urology of Virginia, PLCC
Virginia Beach Virginia, 23462, United States
Fundacion Puigvert
Barcelona , 08025, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Inst. Valenciano de Oncologia
Valencia , 46009, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT03404791

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.