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

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nippon Kayaku Co., Ltd.; Nippon Kayaku Co.,Ltd.
• Collaborators: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Apaziquone

Criteria

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.