Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01373398

Enrollment

Registered

2011-06-15

Start date

2011-05-31

Completion date

Unknown

Last updated

2012-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, EO9, Apaziquone

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).

Interventions

DRUGEO9(Apaziquone)

immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026