Bladder Cancer Clinical Trial
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)
NCT number | NCT01373398 |
Other study ID # | HD901_01 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | June 9, 2011 |
Last updated | March 12, 2012 |
Start date | May 2011 |
Verified date | March 2012 |
Source | Handok Pharmaceuticals Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 11 |
Est. completion date | |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 74 Years |
Eligibility |
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. |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Site 01 | Seoul | |
Korea, Republic of | Site 02 | Seoul |
Lead Sponsor | Collaborator |
---|---|
Handok Pharmaceuticals Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) | 14 weeks | Yes | |
Secondary | pharmacokinetics assessment of EO9 and it's metabolites in blood and urine | before, 30, 55, 90 mins of EO9 instillation | No |
Status | Clinical Trial | Phase | |
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