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NCT02563561 · ClinicalTrials.gov registry record · Phase 3
A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT02563561: Clinical Trial Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT02563561 is a Phase 3 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02563561, a Phase 3 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT. In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2. Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio. Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.
Primary Outcome
Time from randomization to the date of histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment.
Interventions
- OTHER Placebo
- DRUG Apaziquone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-10-09 |
| Est. Completion | 2017-03-10 |
| Phase | Phase 3 |
Why NCT02563561 stopped before completion
NCT02563561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02563561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02563561 about?
NCT02563561 is a clinical study titled "A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)". This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT. In addition to Screening, participan...
What is the current status of trial NCT02563561?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2015-10-09. Estimated completion is 2017-03-10.
What interventions are being tested in trial NCT02563561?
The interventions under investigation include: Placebo (OTHER), Apaziquone (DRUG).
Who is sponsoring clinical trial NCT02563561?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02563561's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 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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