NCT01469221

Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)

A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Apaziquone	6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
DRUG	Placebo	6 weekly multi-instillation of matching placebo in 40mL

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-11-10
• Last updated: 2017-12-15
• Results posted: 2017-12-15

Locations

29 sites across 4 countries: United States, Czechia, Poland, Slovakia