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Virus Therapy

TAR-200 for Bladder Cancer

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12, 24, and 36 months
Awards & highlights

Study Summary

This trial will study the safety and if people can tolerate TAR-200 given for 21 days every 4 weeks.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12, 24, and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Percentage of Participants Surviving at 12, 24, and 36 Months
Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months
Percentage of Participants with Clinical Complete Response (cCR)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants Ineligible for Radical CystectomyExperimental Treatment1 Intervention
Participants will receive the TAR-200 transuretherally on Day 0 in to the bladder through an Inserter and gradually releases gemcitabine during the 21-day indwelling period before being removed on Day 21 via flexible or rigid cystoscopy. Participants will undergo an 84-day induction period comprised of four consecutive 21-day dosing cycles. Participants may undergo 21 day cycle every 3 months for a maximum of 3 cycles as maintenance (Up to 14 months). Each TAR-200 system will be removed at 21 days after insertion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAR-200
2017
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,657 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,960,243 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2017. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03404791.
~5 spots leftby Apr 2025
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