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

NCT01475266 | Terminated Phase 2 DMC

• 2 other identifiers: A9EO9201EO9_C301
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 20

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

Keywords

Bladder Cancer; NMIBC; TURBT; Apaziquone; EOquin; Immediate instillation

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (7)

• 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

Study Arms (2)

EO9 (Apaziquone)

EXPERIMENTAL

Drug: EO9 (Apaziquone)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EO9 (Apaziquone) DRUG

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

Also known as: Eoquin(R)

EO9 (Apaziquone)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have provided written informed consent
• 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.
• Age: ≥20 years old at enrollment.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nippon Kayaku Co., Ltd.: lead
• Handok Inc.: collaborator

Study Sites (20)

Nippon Kayaku Investigational site 103

Yokosuka, Kanagawa, Japan

Location

Nippon Kayaku Investigational site 107

Kashihara, Nara, Japan

Location

Nippon Kayaku Investigational site 109

Kurashiki, Okayama-ken, Japan

Location

Nippon Kayaku Investigational site 105

Sayama, Osaka, Japan

Location

Nippon Kayaku Investigational site 104

Hamamatsu, Shizuoka, Japan

Location

Nippon Kayaku Investigational site 102

Musashino, Tokyo, Japan

Location

Nippon kayaku Investigational site 101

Chiba, Japan

Location

Nippon Kayaku Investigational site 110

Fukuoka, Japan

Location

Nippon Kayaku Investigational site 111

Fukuoka, Japan

Location

Nippon Kayaku Investigational site 106

Nara, Japan

Location

Nippon Kayaku Investigational site 108

Okayama, Japan

Location

Handok Investigational site 203

Bundang, South Korea

Location

Handok Investigational site 202

Daegu, South Korea

Location

Handok Investigational site 209

Hwasun, South Korea

Location

Handok Investigational site 201

Seoul, South Korea

Location

Handok Investigational site 204

Seoul, South Korea

Location

Handok Investigational site 205

Seoul, South Korea

Location

Handok Investigational site 206

Seoul, South Korea

Location

Handok Investigational site 207

Seoul, South Korea

Location

Handok Investigational site 208

Yangsan, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

apaziquone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Yoshihiro Nambu, M.D., Ph.D.

  Nippon Kayaku Co., Ltd.

  STUDY DIRECTOR

• Woo Ick Jang, M.D., Ph.D.

  Handok Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 29, 2017

Record last verified: 2013-04

Locations

JP (11); KR (9)