Overview

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

Status:
Terminated

Trial end date:
2019-09-26

Target enrollment:

Participant gender:

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)

Phase:

Phase 3

Details

Lead Sponsor:

Spectrum Pharmaceuticals, Inc

Treatments:

Apaziquone