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NCT05644041 · ClinicalTrials.gov registry record · Phase 2
Intravesical Gem/Doce in Patients With NMIBC
A Phase 2 study of Urinary Bladder Cancer, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05644041: Recruiting Phase 2 study of Urinary Bladder Cancer, sponsored by University of Arizona.
NCT05644041 is a Phase 2 study of Urinary Bladder Cancer that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05644041, a Phase 2 study of Urinary Bladder Cancer, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem/Doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.
Primary Outcome
The primary outcome measure will be CR rate, defined as the percentage of patients with CR at the 3-month visit. An event will be defined as the earliest date of recurrence as determined using the date of cystoscopy, biopsy, or cytology, whichever occurs first.
Conditions Studied
Interventions
- DRUG gemcitabine + docetaxel
Study Locations (1)
Arizona
- University of Arizona Cancer Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
What NCT05644041 shows while recruiting
NCT05644041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Urinary Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which gemcitabine + docetaxel is the first listed.
NCT05644041 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT05644041 about?
NCT05644041 is a clinical study titled "Intravesical Gem/Doce in Patients With NMIBC". Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-G...
What is the current status of trial NCT05644041?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-03-01. Estimated completion is 2027-01-31.
What conditions does trial NCT05644041 study?
This clinical trial studies the following conditions: Urinary Bladder Cancer.
What interventions are being tested in trial NCT05644041?
The interventions under investigation include: gemcitabine + docetaxel (DRUG).
Who is sponsoring clinical trial NCT05644041?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05644041 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05644041's enrollment target sits among peer trials
25 1719th of 2000 higher than 246 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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