A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)

Summary

This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only participants with the following low-to intermediate-risk tumor characteristics were included in the study. 2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer: Low Risk * Low grade solitary Ta ≤3 centimeters (cm) * Papillary urothelial neoplasm of low malignant potential (PUNLMP) Intermediate Risk * Recurrence within 1 year, low-grade Ta * Solitary low-grade Ta \>3 cm * Low-grade Ta, multifocal * High-grade Ta, ≤3 cm (solitary tumor)

Timeline

Start

2017-08-04

Primary completion

2019-09-26

Completion

2019-09-26

Outcome

Outcome not reported

Stopped: “Suspended development”

Drugs

Indications