Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
- Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1,
G2 urothelial carcinoma of the bladder
- Patients who are confirmed to be urinary cytology negative (class I, class II) within
4 weeks prior to the present TURBT.
- P.S : 0-2 according to the ECOG.
- Patients with a primary and solitary tumor.
- CIS lesions in the bladder or a history thereof.
- Grade 3 disease or a history thereof.
- Patients experiencing recurrence within 3 months following TURBT for prior NMIBC.
- Patients having stage T1 and high-grade disease.
- Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis,
or a history thereof.
- Patients who received intravesical chemotherapy/immunotherapy treatment within 6
months prior to the present TURBT.
- Patients who underwent systemic chemotherapy or radiotherapy whose field of exposure
included the bladder.
- Patients with suspected bladder perforation at the time of the present TURBT.
- A complication of a malignant tumor of the upper urinary tract or urethra, or a
- Malignancy within 5 years other than NMIBC (except thyroid cancer)
- A serious viral or bacterial infection within the last 4 weeks.