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

This study has been terminated.
(Sponsor's decision)
Sponsor:
Collaborator:
Handok Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01475266
First received: November 16, 2011
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: EO9 (Apaziquone)
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC

Resource links provided by NLM:


Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The progression rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The number of recurrences per patient [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The progression-free survival period [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The recurrence-free survival period [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The overall survival period [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The safety of EO9 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: November 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EO9 (Apaziquone) Drug: EO9 (Apaziquone)
4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
Other Name: Eoquin(R)
Placebo Comparator: Placebo Drug: Placebo
40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475266

Locations
Japan
Nippon Kayaku Investigational site 103
Yokosuka, Kanagawa, Japan
Nippon Kayaku Investigational site 107
Kashihara, Nara, Japan
Nippon Kayaku Investigational site 109
Kurashiki, Okayama, Japan
Nippon Kayaku Investigational site 105
Osakasayama, 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
Korea, Republic of
Handok Investigational site 203
Bundang, Korea, Republic of
Handok Investigational site 202
Daegu, Korea, Republic of
Handok Investigational site 209
Hwasun, 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
Seoul, Korea, Republic of
Handok Investigational site 208
Yangsan, Korea, Republic of
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Handok Pharmaceuticals Co., Ltd.
Investigators
Study Director: Yoshihiro Nambu, M.D., Ph.D. Nippon Kayaku Co.,Ltd.
Study Director: Woo Ick Jang, M.D., Ph.D. Handok Pharmaceuticals Co., Ltd.
  More Information

No publications provided

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01475266     History of Changes
Other Study ID Numbers: A9EO9201, EO9_C301
Study First Received: November 16, 2011
Last Updated: April 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Nippon Kayaku Co.,Ltd.:
Bladder Cancer
NMIBC
TURBT
Apaziquone
EOquin
Immediate instillation

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Apaziquone
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014