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Brief Title: Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy

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


  • Org Study ID: CR108889
  • Secondary ID: N/A
  • NCT ID: NCT03404791
  • Sponsor: Janssen Research & Development, LLC


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.

  • Overall Status
  • Start Date
    November 20, 2017
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Urinary Bladder Neoplasms


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: N/A

Phone: N/A

Email: N/A


Facility Status Contact