NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-101285

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNon-muscle invasive bladder carcinoma
Date of first enrollment01/10/2010
Target sample size6
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : EO9 Dosage And administration of the intervention : Intravesical Instillation Control intervention name : null

Outcome(s)

Primary OutcomeSafety
Secondary OutcomePharmacokinetics

Key inclusion & exclusion criteria

Age minimum20
Age maximum74
GenderBOTH
Include criteria(1) Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder and satisfy both of the following criteria: The maximum number of tumors is 5. Tumor diameter:< 3.5 cm. (2) The functions of the major organs are adequate, and the following test value criteria are satisfied. (These tests will be performed within 4 weeks prior to the present TURBT.) WBC count >-3,000 /uL Platelet count >-10x104 /uL AST, ALT <2.5 times the institutional upper limit of normal Total bilirubin <1.5 times the institutional upper limit of normal Serum creatinine -<1.5 mg /dL Hemoglobin >-9.5 g/dL
Exclude criteria(1) Patients with a primary and solitary tumor. (2) CIS lesions in the bladder or a history thereof. (3) Grade 3 disease or a history thereof. (4) Patients experiencing recurrence within 3 months following TURBT for prior NMIBC. (5) Patients having stage T1 and high-grade disease. (6) Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof. (7) Patients who received intravesical chemotherapy treatment within 6 months prior to the present TURBT.

Related Information

Contact

public contact
Name Nippon Kayaku Co., LTD. Pharmaceutical Development Division, Clinical Development
Address FAX +81-3-3598-5423
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scientific contact
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