Status:
TERMINATED
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Lead Sponsor:
Nippon Kayaku Co., Ltd.
Collaborating Sponsors:
Handok Inc.
Conditions:
Bladder Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01475266
Start Date
November 1 2011
End Date
April 1 2013
Last Update
March 29 2017
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Nippon Kayaku Investigational site 103
Yokosuka, Kanagawa, Japan
2
Nippon Kayaku Investigational site 107
Kashihara, Nara, Japan
3
Nippon Kayaku Investigational site 109
Kurashiki, Okayama-ken, Japan
4
Nippon Kayaku Investigational site 105
Sayama, Osaka, Japan