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

NCT01475266 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-03-29

No results posted yet for this study

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

Interventions

DRUG

EO9 (Apaziquone)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Handok Inc.

    collaborator INDUSTRY

  • Nippon Kayaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshihiro Nambu, M.D., Ph.D. · Nippon Kayaku Co., Ltd.

  • Woo Ick Jang, M.D., Ph.D. · Handok Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475266 on ClinicalTrials.gov