Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
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 from randomization. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)|
- Time to Recurrence [ Time Frame: Recurrence of cancer in the bladder during 24 months of follow-up ] [ Designated as safety issue: No ]Time to recurrence (from randomization) for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo.
- Recurrence rate at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Recurrence Rate at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: 24 Months after Randomization ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: 24 Months from Randomization ] [ Designated as safety issue: Yes ]Safety and Tolerability will be mainly characterized by the number and severity of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Apaziquone||
Apaziquone 4 mg in 40 mL diluent
Placebo Comparator: Placebo
Placebo for Double Blind Phase
Show 47 Study Locations
|Principal Investigator:||Randil Clark, MD||North Idaho Urology|