Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Apaziquone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 history thereof.

• Malignancy within 5 years other than NMIBC (except thyroid cancer)

• A serious viral or bacterial infection within the last 4 weeks.