Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC

Nippon Kayaku Co., Ltd.20 sites in 2 countries51 target enrollmentNovember 2011

ConditionsBladder Cancer

InterventionsPlacebo EO9 (Apaziquone)

DrugsEO9 (Apaziquone)Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Bladder Cancer
Sponsor: Nippon Kayaku Co., Ltd.
Enrollment: 51
Locations: 20
Primary Endpoint: The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

April 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nippon Kayaku Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who have provided written informed consent
•Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:
•The maximum number of tumors is
•Each tumor diameter: ≤ 3.5 cm.
•Age: ≥20 years old at enrollment.
•The functions of the major organs are adequate, and the following test value criteria are satisfied:
•Neutrophil count ≥1,500/μL
•Platelet count ≥10×10\^4/μL
•Hemoglobin ≥10 g/dL

Exclusion Criteria

•Patients with a single, primary bladder cancer of \<0.5 cm.
•Patients with CIS lesions in the bladder or a history thereof.
•Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
•Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).
•Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
•Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.
•Patients who had been administered EO9 in the past.
•Patients who had been administered any other investigational drug within the past 30 days.
•Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.

Arms & Interventions

Placebo

Intervention: Placebo

EO9 (Apaziquone)

Intervention: EO9 (Apaziquone)

Outcomes

Primary Outcomes

The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer

Time Frame: 2 years

Secondary Outcomes

The safety of EO9(2 years)
The number of recurrences per patient(2 years)
The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer(2 years)
The progression rate(2 years)
The progression-free survival period(2 years)
The recurrence-free survival period(2 years)
The overall survival period(2 years)