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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 9, 2011
Last Updated Date	March 12, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2011)	Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01373398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 13, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
Official Title ^ICMJE	Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Bladder Cancer
Intervention ^ICMJE	Drug: EO9(Apaziquone) immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	11
Completion Date	Not Provided
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01373398
Other Study ID Numbers ^ICMJE	HD901_01
Has Data Monitoring Committee	No
Responsible Party	Handok Pharmaceuticals Co., Ltd.
Study Sponsor ^ICMJE	Handok Pharmaceuticals Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Handok Pharmaceuticals Co., Ltd.
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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