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

Nippon Kayaku

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Bladder Cancer

Treatments: Drug: Placebo; Drug: EO9 (Apaziquone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475266

EO9_C301

A9EO9201

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have provided written informed consent

2. 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.

3. Age: ≥20 years old at enrollment.

4. 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

1. Patients with a single, primary bladder cancer of <0.5 cm.
2. Patients with CIS lesions in the bladder or a history thereof.
3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
4. 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).
5. Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
6. Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.
7. Patients who had been administered EO9 in the past.
8. Patients who had been administered any other investigational drug within the past 30 days.
9. Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

EO9 (Apaziquone)

Experimental group

Treatment:

Drug: EO9 (Apaziquone)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo