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

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

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.

Study Overview

• Status: Terminated
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: EO9 (Apaziquone); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
    • Nippon kayaku Investigational site 101
  • Fukuoka, Japan
    • Nippon Kayaku Investigational site 110
  • Fukuoka, Japan
    • Nippon Kayaku Investigational site 111
  • Nara, Japan
    • Nippon Kayaku Investigational site 106
  • Okayama, Japan
    • Nippon Kayaku Investigational site 108
  • Kanagawa
    • Yokosuka, Kanagawa, Japan
      • Nippon Kayaku Investigational site 103
  • Nara
    • Kashihara, Nara, Japan
      • Nippon Kayaku Investigational site 107
  • Okayama
    • Kurashiki, Okayama, Japan
      • Nippon Kayaku Investigational site 109
  • Osaka
    • Osakasayama, Osaka, Japan
      • Nippon Kayaku Investigational site 105
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
      • Nippon Kayaku Investigational site 104
  • Tokyo
    • Musashino, Tokyo, Japan
      • Nippon Kayaku Investigational site 102
• Korea, Republic of
  • Bundang, Korea, Republic of
    • Handok Investigational site 203
  • Daegu, Korea, Republic of
    • Handok Investigational site 202
  • Hwasun, Korea, Republic of
    • Handok Investigational site 209
  • Seoul, Korea, Republic of
    • Handok Investigational site 201
  • Seoul, Korea, Republic of
    • Handok Investigational site 204
  • Seoul, Korea, Republic of
    • Handok Investigational site 205
  • Seoul, Korea, Republic of
    • Handok Investigational site 206
  • Seoul, Korea, Republic of
    • Handok Investigational site 207
  • Yangsan, Korea, Republic of
    • Handok Investigational site 208

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nippon Kayaku Co., Ltd.
• Collaborators: Handok Inc.
• Investigators: Study Director: Yoshihiro Nambu, M.D., Ph.D., Nippon Kayaku Co., Ltd.; Study Director: Woo Ick Jang, M.D., Ph.D., HANDOK Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: NMIBC; Bladder Cancer; TURBT; Apaziquone; EOquin; Immediate instillation
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Antineoplastic Agents; Apaziquone
• Other Study ID Numbers: A9EO9201; EO9_C301