Trials / Completed
CompletedNCT02722538
Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Muscle-Invasive Transitional Cell Carcinoma of the Bladder
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Taris Biomedical LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 | TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical drug delivery system, regulated as a drug, whose primary mode of action is the controlled release of gemcitabine into the bladder over a 7-day period. |
Timeline
- Start date
- 2016-05-31
- Primary completion
- 2019-05-02
- Completion
- 2019-05-02
- First posted
- 2016-03-30
- Last updated
- 2023-09-18
Locations
6 sites across 2 countries: United States, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02722538. Inclusion in this directory is not an endorsement.