CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 802 enrolled
Drug / intervention
Apaziquone +2 moredrug
Likely dose
Apaziquone 4 mg in 40 mL intravesical instillation, single dose post-TURBTAI-extracted
Key inclusion· 4
  • ✓Diagnosis of transitional cell carcinoma of the bladder, clinically apparent stage Ta, grade G1-G2
  • ✓Age at least 18 years
  • ✓Written informed consent obtained
  • ✓Willing and able to abide by the protocol
Key exclusion· 14
  • ✕More than 4 bladder tumors
  • ✕Any single bladder tumor exceeding 3.5 cm in diameter
  • ✕Single, primary bladder tumor smaller than 0.5 cm
  • ✕Prior diagnosis of high-grade bladder cancer or stage other than Ta, or non-Ta/non-G1-G2 histology

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00461591
NCT00461591Phase 3Completed
CompareCT.gov

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-611)

Spectrum Pharmaceuticals, Inc·interventional·Posted Apr 18, 2007·Updated Mar 30, 2021

In Brief

A Phase 3 clinical trial evaluating Apaziquone, Placebo, and 1 other intervention for Bladder Cancer. Completed, enrolled 802 participants across 74 sites.

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
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2007
Enrollment StartApr 1, 2007
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.2 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