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

June 9, 2011
March 12, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01373398 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Bladder Cancer
Drug: EO9(Apaziquone)
immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
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.
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01373398
HD901_01
No
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