Trials / Completed
CompletedNCT02720367
Safety and Tolerability of TAR-200 mg in Subjects With Non-Muscle-Invasive Bladder Cancer
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (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 recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 | TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical system whose primary mode of action is the controlled release of gemcitabine into the bladder over an indwelling period. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2018-01-01
- Completion
- 2020-03-01
- First posted
- 2016-03-25
- Last updated
- 2020-03-10
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02720367. Inclusion in this directory is not an endorsement.