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Status:

COMPLETED

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

Lead Sponsor:

Janssen Research & Development, LLC

Conditions:

Urinary Bladder Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 20 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 15 2022

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT03404791

Start Date

November 20 2017

End Date

September 15 2022

Last Update

February 4 2025

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

2

North Georgia Urology Center

Dalton, Georgia, United States, 30720

3

Chesapeake Urology Research Associates

Hanover, Maryland, United States, 21076

4

Michigan Institute of Urology

Troy, Michigan, United States, 48084