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

Bladder Cancer Clinical Trial

Official title:

Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01475266
• Other study ID #: A9EO9201
• Secondary ID: EO9_C301
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 16, 2011
• Last updated: March 27, 2017
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Nippon Kayaku Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• EO9 (Apaziquone)
4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
• Placebo
40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Locations

Country	Name	City	State
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 104	Hamamatsu	Shizuoka
Japan	Nippon Kayaku Investigational site 107	Kashihara	Nara
Japan	Nippon Kayaku Investigational site 109	Kurashiki	Okayama
Japan	Nippon Kayaku Investigational site 102	Musashino	Tokyo
Japan	Nippon Kayaku Investigational site 106	Nara
Japan	Nippon Kayaku Investigational site 108	Okayama
Japan	Nippon Kayaku Investigational site 105	Osakasayama	Osaka
Japan	Nippon Kayaku Investigational site 103	Yokosuka	Kanagawa
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

Sponsors (2)

Lead Sponsor	Collaborator
Nippon Kayaku Co.,Ltd.	Handok Pharmaceuticals Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer		2 years
Secondary	The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer		2 years
Secondary	The progression rate		2 years
Secondary	The number of recurrences per patient		2 years
Secondary	The progression-free survival period		2 years
Secondary	The recurrence-free survival period		2 years
Secondary	The overall survival period		2 years
Secondary	The safety of EO9		2 years