Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

This study has been completed.
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd. Identifier:
First received: June 9, 2011
Last updated: March 12, 2012
Last verified: March 2012

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).

Condition Intervention Phase
Bladder Cancer
Drug: EO9(Apaziquone)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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)

Resource links provided by NLM:

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics assessment of EO9 and it's metabolites in blood and urine [ Time Frame: before, 30, 55, 90 mins of EO9 instillation ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: EO9(Apaziquone)
    immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01373398

Korea, Republic of
Site 01
Seoul, Korea, Republic of
Site 02
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
  More Information

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd. Identifier: NCT01373398     History of Changes
Other Study ID Numbers: HD901_01
Study First Received: June 9, 2011
Last Updated: March 12, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 15, 2014