Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
NCT ID: NCT01373398
Last Updated: 2012-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Interventions
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EO9(Apaziquone)
immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
74 Years
ALL
No
Sponsors
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Handok Inc.
INDUSTRY
Responsible Party
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Locations
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Site 01
Seoul, , South Korea
Site 02
Seoul, , South Korea
Countries
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Other Identifiers
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HD901_01
Identifier Type: -
Identifier Source: org_study_id
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