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

Phase 3

Terminated

• Conditions: Bladder Cancer
• Interventions: Drug: Apaziquone; Drug: Placebo

• Registration Number: NCT01469221
• Lead Sponsor: Spectrum Pharmaceuticals, Inc

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

Not available

Study Timeline

• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-10
• Study Start: 2012-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2017-10
• Results First Submitted: 2017-10-17
• Results First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Results First Posted: 2017-12-15
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apaziquone	Apaziquone	Apaziquone (4 mg in 40 mL)
Placebo	Placebo	Matching placebo (40 mL)

Primary Outcome Measures

Name	Time	Method
Time to Recurrence	24 Months	Time from randomization to the date of first histologically confirmed recurrence of bladder cancer

Secondary Outcome Measures

Name	Time	Method
2-Year Recurrence Rate	24 Months	Proportion of patients with recurrence at or before 24 months

Trial Locations

Locations (28)

Tower Research Institute; 🇺🇸 Los Angeles, California, United States

Department of Urology, University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Somerset Urological Associates, PA; 🇺🇸 Somerville, New Jersey, United States

Associated Medical Professionals of New York, PLLC; 🇺🇸 Syracuse, New York, United States

Male and Female Urology; 🇺🇸 Staten Island, New York, United States

Alliance Urology Specialists; 🇺🇸 Greensboro, North Carolina, United States

Nemocnice Jablonec nad Nisou, Urologické oddělení; 🇨🇿 Jablonec nad Nisou, Czechia

Fakultní Thomayerova nemocnice s poliklinikou Urologické oddělení; 🇨🇿 Prague, Czechia

Szpital Miejski im. Prof. E. Michałowskiego; 🇵🇱 Katowice, Poland

CenterMed Kraków sp z o.o.; 🇵🇱 Kraków, Poland

Scroll for more (18 remaining)