Non-muscle invasive bladder carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : EO9
INN of investigational material :
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for In
Sponsors
Nippon Kayaku Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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:-3,000 /uL Platelet count >-10x104 /uL AST, ALT -9.5 g/dL
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Outcome results
None listed