Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
This is an international, multicenter, double-blind, placebo-controlled, randomized study.
All eligible patients entering the open label phase of the study will receive a single
immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral
resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double
Blind Phase qualification, patients with confirmed eligibility will be randomized to receive
either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo
cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic
evidence of recurrent disease during the study will be treated according to current treatment
guidelines or local standard of care. Safety and efficacy assessments will be performed at 3
month intervals for all randomized patients throughout the study. Patients who receive single
dose of apaziquone immediately following TURBT and are not eligible for randomization will be
followed for 3 months by cystoscopic exam and safety assessments.