Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: EO9 (Apaziquone)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 5. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EO9 (Apaziquone)<br> | Drug: EO9 (Apaziquone)<br>* 4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT<br>* Other names: Eoquin(R);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 40 mL, Intravesical instillation, Single dose within 6 hours after TURBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 number of recurrences per patient |  | 2 years | 
| The progression-free survival period |  | 2 years | 
| The recurrence-free survival period |  | 2 years | 
| The overall survival period |  | 2 years | 
| The safety of EO9 |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder Cancer, NMIBC, TURBT, Apaziquone, EOquin, Immediate instillation