Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

Bladder Cancer Clinical Trial

Official title:

Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373398
• Other study ID #: HD901_01
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2011
• Last updated: March 12, 2012
• Start date: May 2011

Study information

• Verified date: March 2012
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• EO9(Apaziquone)
immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone

Locations

Country	Name	City	State
Korea, Republic of	Site 01	Seoul
Korea, Republic of	Site 02	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)		14 weeks	Yes
Secondary	pharmacokinetics assessment of EO9 and it's metabolites in blood and urine		before, 30, 55, 90 mins of EO9 instillation	No