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NCT05085977 · ClinicalTrials.gov registry record · Phase 1
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)
A Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by Protara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 14
- Study locations
NCT05085977: Completed Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by Protara Therapeutics.
NCT05085977 is a Phase 1 study of Non-muscle Invasive Bladder Cancer that has completed, run by Protara Therapeutics. The registered enrollment target is 12 participants, below the 226-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05085977, a Phase 1 study of Non-muscle Invasive Bladder Cancer, has completed, sponsored by Protara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 14
- Study locations
Study Summary
This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.
Primary Outcome
DLT = dose limiting toxicities; HGTa = high grade Ta; CIS = carcinoma in situ, includes CIS with concomitant Ta
Conditions Studied
Interventions
- BIOLOGICAL TARA-002
Study Locations (14)
Other
- PMSI Republican Clinical Hospital "T. Mosneaga," ARENSIA Exploratory Medicine Phase I Unit - Chisinau
- Spitalul Clinic de Nefrologie Carol Davila - Bucharest
- Arensia Kapitanivka - Kapitanivka
New York
- Premier Medical Group of the Hudson Valley - Poughkeepsie
- University of Rochester, Department of Urology - Rochester
California
- USC Norris Cancer Center - Los Angeles
Florida
- Mayo Clinic - Jacksonville
Louisiana
- Tulane Medical Center - New Orleans
Maryland
- Chesapeake Urology Research Associates - Baltimore
Minnesota
- Mayo Clinic - Rochester
New Jersey
- New Jersey Urology - Mount Laurel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 1 |
What the finished NCT05085977 record still lists
NCT05085977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 226-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which TARA-002 is the first listed.
NCT05085977 lists 14 locations in 11 states (Other, New York, California).
Frequently Asked Questions
What is clinical trial NCT05085977 about?
NCT05085977 is a clinical study titled "Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)". This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to o...
What is the current status of trial NCT05085977?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-03-10. Estimated completion is 2024-10-30.
What conditions does trial NCT05085977 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.
What interventions are being tested in trial NCT05085977?
The interventions under investigation include: TARA-002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05085977?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05085977 being conducted?
This trial has 14 study locations across California, Florida, Louisiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05085977's enrollment target sits among peer trials
12 30th of 30 higher than 1 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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