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Trial record 1 of 1 for:    NCT01475266
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Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)

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ClinicalTrials.gov Identifier: NCT01475266
Recruitment Status : Terminated (Sponsor's decision)
First Posted : November 21, 2011
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Handok Inc.
Information provided by (Responsible Party):
Nippon Kayaku Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: EO9 (Apaziquone) Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer [ Time Frame: 2 years ]
  2. The progression rate [ Time Frame: 2 years ]
  3. The number of recurrences per patient [ Time Frame: 2 years ]
  4. The progression-free survival period [ Time Frame: 2 years ]
  5. The recurrence-free survival period [ Time Frame: 2 years ]
  6. The overall survival period [ Time Frame: 2 years ]
  7. The safety of EO9 [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475266


Locations
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Sponsors and Collaborators
Nippon Kayaku Co., Ltd.
Handok Inc.
Investigators
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Study Director: Yoshihiro Nambu, M.D., Ph.D. Nippon Kayaku Co., Ltd.
Study Director: Woo Ick Jang, M.D., Ph.D. Handok Inc.
More Information
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Responsible Party: Nippon Kayaku Co., Ltd.
ClinicalTrials.gov Identifier: NCT01475266    
Other Study ID Numbers: A9EO9201
EO9_C301
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: April 2013
Keywords provided by Nippon Kayaku Co., Ltd.:
Bladder Cancer
NMIBC
TURBT
 Apaziquone
EOquin
Immediate instillation
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Urinary Bladder Diseases
Urologic Diseases
Apaziquone
Antineoplastic Agents