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NCT01469221 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 47
- Enrollment target
NCT01469221 is a Phase 3 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 47 participants.
The verdict
NCT01469221, a Phase 3 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 47 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. 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.
Interventions
- DRUG Placebo
- DRUG Apaziquone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01469221
The ClinicalTrials.gov registry entry for NCT01469221 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectrum Pharmaceuticals, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01469221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01469221 about?
NCT01469221 is a clinical study titled "Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)". 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 NCT01469221?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2012-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01469221?
The interventions under investigation include: Placebo (DRUG), Apaziquone (DRUG).
Who is sponsoring clinical trial NCT01469221?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
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