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

NCT ID: NCT01475266

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EO9 (Apaziquone)

Group Type: EXPERIMENTAL

EO9 (Apaziquone)

Intervention Type: DRUG

4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Interventions

EO9 (Apaziquone)

4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Intervention Type: DRUG

Placebo

40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Intervention Type: DRUG

Other Intervention Names

Eoquin(R)

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Handok Inc.

INDUSTRY

Sponsor Role: collaborator

Nippon Kayaku Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshihiro Nambu, M.D., Ph.D.

Role: STUDY_DIRECTOR

Nippon Kayaku Co., Ltd.

Woo Ick Jang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Handok Inc.

Locations

Nippon Kayaku Investigational site 103

Yokosuka, Kanagawa, Japan

Nippon Kayaku Investigational site 107

Kashihara, Nara, Japan

Nippon Kayaku Investigational site 109

Kurashiki, Okayama-ken, Japan

Nippon Kayaku Investigational site 105

Sayama, Osaka, Japan

Nippon Kayaku Investigational site 104

Hamamatsu, Shizuoka, Japan

Nippon Kayaku Investigational site 102

Musashino, Tokyo, Japan

Nippon kayaku Investigational site 101

Chiba, , Japan

Nippon Kayaku Investigational site 110

Fukuoka, , Japan

Nippon Kayaku Investigational site 111

Fukuoka, , Japan

Nippon Kayaku Investigational site 106

Nara, , Japan

Nippon Kayaku Investigational site 108

Okayama, , Japan

Handok Investigational site 203

Bundang, , South Korea

Handok Investigational site 202

Daegu, , South Korea

Handok Investigational site 209

Hwasun, , South Korea

Handok Investigational site 201

Seoul, , South Korea

Handok Investigational site 204

Seoul, , South Korea

Handok Investigational site 205

Seoul, , South Korea

Handok Investigational site 206

Seoul, , South Korea

Handok Investigational site 207

Seoul, , South Korea

Handok Investigational site 208

Yangsan, , South Korea

Countries

Japan; South Korea

Other Identifiers

EO9_C301

Identifier Type: -

Identifier Source: secondary_id

A9EO9201

Identifier Type: -

Identifier Source: org_study_id