Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01373398
First received: June 9, 2011
Last updated: March 12, 2012
Last verified: March 2012
  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: 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
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov 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
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014