Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373398
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.

June 9, 2011
June 15, 2011
March 13, 2012
May 2011
February 2012   (Final data collection date for primary outcome measure)
Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) [ Time Frame: 14 weeks ]
Same as current
Complete list of historical versions of study NCT01373398 on Archive Site
pharmacokinetics assessment of EO9 and it's metabolites in blood and urine [ Time Frame: before, 30, 55, 90 mins of EO9 instillation ]
Same as current
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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)
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).
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Bladder Cancer
Drug: EO9(Apaziquone)
immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Handok Pharmaceuticals Co., Ltd.
Handok Pharmaceuticals Co., Ltd.
Not Provided
Not Provided
Handok Pharmaceuticals Co., Ltd.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP