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

Phase 2

Terminated

• Conditions: Bladder Cancer
• Interventions: Drug: EO9 (Apaziquone); Drug: Placebo

• Registration Number: NCT01475266
• Lead Sponsor: Nippon Kayaku Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-21
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EO9 (Apaziquone)	EO9 (Apaziquone)	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The progression rate	2 years
The progression-free survival period	2 years
The recurrence-free survival period	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 overall survival period	2 years
The safety of EO9	2 years

Trial Locations

Locations (20)

Nippon Kayaku Investigational site 107; 🇯🇵 Kashihara, Nara, Japan

Nippon Kayaku Investigational site 110; 🇯🇵 Fukuoka, Japan

Nippon Kayaku Investigational site 103; 🇯🇵 Yokosuka, Kanagawa, Japan

Nippon Kayaku Investigational site 108; 🇯🇵 Okayama, Japan

Nippon Kayaku Investigational site 104; 🇯🇵 Hamamatsu, Shizuoka, Japan

Nippon Kayaku Investigational site 109; 🇯🇵 Kurashiki, Okayama, Japan

Nippon Kayaku Investigational site 105; 🇯🇵 Osakasayama, Osaka, Japan

Nippon Kayaku Investigational site 102; 🇯🇵 Musashino, Tokyo, Japan

Nippon Kayaku Investigational site 111; 🇯🇵 Fukuoka, Japan

Handok Investigational site 203; 🇰🇷 Bundang, Korea, Republic of

Nippon Kayaku Investigational site 106; 🇯🇵 Nara, Japan

Handok Investigational site 202; 🇰🇷 Daegu, Korea, Republic of

Handok Investigational site 209; 🇰🇷 Hwasun, Korea, Republic of

Handok Investigational site 204; 🇰🇷 Seoul, Korea, Republic of

Handok Investigational site 201; 🇰🇷 Seoul, Korea, Republic of

Handok Investigational site 205; 🇰🇷 Seoul, Korea, Republic of

Handok Investigational site 208; 🇰🇷 Yangsan, Korea, Republic of

Handok Investigational site 207; 🇰🇷 Seoul, Korea, Republic of

Handok Investigational site 206; 🇰🇷 Seoul, Korea, Republic of

Nippon kayaku Investigational site 101; 🇯🇵 Chiba, Japan