Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

Phase 1

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT01373398
• Lead Sponsor: Handok Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-15
• Primary Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)	14 weeks

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics assessment of EO9 and it's metabolites in blood and urine	before, 30, 55, 90 mins of EO9 instillation

Trial Locations

Locations (2)

Site 02; 🇰🇷 Seoul, Korea, Republic of

Site 01; 🇰🇷 Seoul, Korea, Republic of