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

November 16, 2011
April 15, 2013
November 2011
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01475266 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bladder Cancer
  • Drug: EO9 (Apaziquone)
    4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
    Other Name: Eoquin(R)
  • Drug: Placebo
    40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
  • Experimental: EO9 (Apaziquone)
    Intervention: Drug: EO9 (Apaziquone)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Japan
 
NCT01475266
A9EO9201, EO9_C301
Yes
Nippon Kayaku Co.,Ltd.
Nippon Kayaku Co.,Ltd.
Handok Pharmaceuticals Co., Ltd.
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.
Nippon Kayaku Co.,Ltd.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP