Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

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.

Timeline

Start

2007-08

Primary completion

2012-01

Completion

2012-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Apaziquone vs Placebo; p = 0.1094; Odds Ratio (OR) 0.76 (95% CI 0.55 to 1.06); Cochran-Mantel-Haenszel NCT00598806 ↗

Drugs

Indications