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NCT00461591 · ClinicalTrials.gov registry record · Phase 3
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
NCT00461591: Completed Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT00461591 is a Phase 3 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 802 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00461591, a Phase 3 study, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
Primary Outcome
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
Interventions
- DRUG Placebo
- PROCEDURE TURBT
- DRUG Apaziquone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2007-04 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00461591 record still lists
NCT00461591 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00461591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00461591 about?
NCT00461591 is a clinical study titled "Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)". The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
What is the current status of trial NCT00461591?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2007-04. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00461591?
The interventions under investigation include: Placebo (DRUG), TURBT (PROCEDURE), Apaziquone (DRUG).
Who is sponsoring clinical trial NCT00461591?
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 NCT00461591's enrollment target sits among peer trials
802 413th of 2000 higher than 1,587 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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