At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 812 enrolled
Drug / intervention
Apaziquone +2 moredrug
Likely dose
Apaziquone 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-612)
In Brief
A Phase 3 clinical trial evaluating Apaziquone, Placebo, and 1 other intervention for Bladder Cancer. Completed, enrolled 812 participants across 77 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesCanada, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedJan 2008
Primary CompletionJan 2012
TodayJul 2026
First PostedJan 23, 2008
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.4 years ago
Interventions
Apaziquonedrug
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebodrug
A single intravesical dose of placebo instilled into the bladder post-TURBT
TURBTprocedure
TransUrethral Resection of the Bladder Tumor