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NCT01410565 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
NCT01410565: Clinical Trial Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT01410565 is a Phase 3 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 66 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410565, a Phase 3 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
Study Summary
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.
Primary Outcome
Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).
Interventions
- DRUG Placebo
- DRUG Apaziquone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
Why NCT01410565 stopped before completion
NCT01410565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01410565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01410565 about?
NCT01410565 is a clinical study titled "Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer". This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Followin...
What is the current status of trial NCT01410565?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2011-07. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01410565?
The interventions under investigation include: Placebo (DRUG), Apaziquone (DRUG).
Who is sponsoring clinical trial NCT01410565?
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 NCT01410565's enrollment target sits among peer trials
66 1797th of 2000 higher than 204 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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