EO9 Phase I Study (Intravesical Instillation)
- Conditions
- on-muscle invasive bladder carcinoma
- Registration Number
- JPRN-jRCT2080221248
- Lead Sponsor
- ippon Kayaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 6
(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/d
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Pharmacokinetics