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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 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 233-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 11 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05085977
The ClinicalTrials.gov registry entry for NCT05085977 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Protara Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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