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NCT04688931 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
A Phase 3 study, sponsored by UroGen Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 282
- Enrollment target
NCT04688931: Clinical Trial Phase 3 study, sponsored by UroGen Pharma.
NCT04688931 is a Phase 3 study that was terminated before completion, run by UroGen Pharma. The registered enrollment target is 282 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04688931, a Phase 3 study, was terminated before completion, sponsored by UroGen Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 282 participants
- Enrollment target
Study Summary
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Primary Outcome
DFS is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), progression to high-grade (HG) disease, or death due to any cause. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization.
Interventions
- PROCEDURE TURBT
- DRUG UGN-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2021-02-19 |
| Est. Completion | 2023-03-17 |
| Phase | Phase 3 |
Why NCT04688931 stopped before completion
NCT04688931 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which TURBT is the first listed.
NCT04688931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04688931 about?
NCT04688931 is a clinical study titled "A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer". This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grad...
What is the current status of trial NCT04688931?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2021-02-19. Estimated completion is 2023-03-17.
What interventions are being tested in trial NCT04688931?
The interventions under investigation include: TURBT (PROCEDURE), UGN-102 (DRUG).
Who is sponsoring clinical trial NCT04688931?
This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04688931's enrollment target sits among peer trials
282 1194th of 2000 higher than 807 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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