Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

Handok

Status and phase: Completed; Phase 1

Conditions: Bladder Cancer

Treatments: Drug: EO9(Apaziquone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01373398

HD901_01

Details and patient eligibility

About

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).

Enrollment: 11 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.