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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EO9(Apaziquone) | Drug | immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics assessment of EO9 and it's metabolites in blood and urine | before, 30, 55, 90 mins of EO9 instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Seoul | South Korea | ||||
| Site 02 |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Seoul |
| South Korea |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |