Conditions: Bladder Cancer
Keywords: Bladder Cancer Non-Muscle Invasive Bladder Cancer NMIBC Apaziquone EOquin GU Cancer TURBT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Apaziquone (4 mg in 40 mL) arm 2: Matching placebo (40 mL)

Interventions: intervention 1: Apaziquone intervention 2: Placebo
Intervention descriptions: intervention 1: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL intervention 2: 6 weekly multi-instillation of matching placebo in 40mL

Protocol document: