Trials / Completed
CompletedNCT03404791
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
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAR-200 | TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant. |
Timeline
- Start date
- 2017-11-20
- Primary completion
- 2019-12-23
- Completion
- 2022-09-15
- First posted
- 2018-01-19
- Last updated
- 2025-02-04
Locations
12 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03404791. Inclusion in this directory is not an endorsement.