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Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373398
First Posted: June 15, 2011
Last Update Posted: March 13, 2012
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.
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373398


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

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01373398     History of Changes
Other Study ID Numbers: HD901_01
First Submitted: June 9, 2011
First Posted: June 15, 2011
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
bladder cancer
EO9
Apaziquone

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Apaziquone
Antineoplastic Agents