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NCT05951179 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
A Phase 2 study of Non-muscle Invasive Bladder Cancer, sponsored by Protara Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT05951179 is a Phase 2 study of Non-muscle Invasive Bladder Cancer that is actively recruiting participants, run by Protara Therapeutics. The registered enrollment target is 131 participants, below the 228-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT05951179, a Phase 2 study of Non-muscle Invasive Bladder Cancer, is actively recruiting participants, sponsored by Protara Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
Study Summary
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF. Participants will be enrolled into one of 2 cohorts: Cohort A: * Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: * Participants who are BCG unresponsive
Conditions Studied
Interventions
- BIOLOGICAL TARA-002
Study Locations (20)
California
- Michael Oefelein Clinical Trials - Bakersfield
- Urology Group of Southern California - Los Angeles
- University of California Irvine Medical Center - Orange
- Genesis Research - San Diego
- Genesis Research LLC - Torrance
Colorado
- Colorado University - Anshutz - Aurora
- AdventHealth Medical Group Urology of Denver - Denver
- Advanced Urology - Lakewood
- Urology Associates of Denver - Lone Tree
Arizona
- Mayo Clinic - Phoenix
- East Valley Urology Center of Arizona - Queen Creek
Florida
- University of Florida Health Jacksonville - Gainesville
- Mayo Clinic - Jacksonville
Louisiana
- Southern Urology - Lafayette
- Ochsner Health LSU - Regional Urology - Shreveport
Alabama
- Urology Centers of Alabama - Homewood
Arkansas
- Arkansas Urology - Little Rock
Illinois
- Comprehensive Urologic Care - Lake Barrington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2023-09-15 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05951179
The ClinicalTrials.gov registry entry for NCT05951179 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (43% 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.
NCT05951179 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT05951179 about?
NCT05951179 is a clinical study titled "Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer". TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-0...
What is the current status of trial NCT05951179?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2023-09-15. Estimated completion is 2030-08.
What conditions does trial NCT05951179 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.
What interventions are being tested in trial NCT05951179?
The interventions under investigation include: TARA-002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05951179?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05951179 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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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