Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
This study has been completed.
Sponsor:
Handok Pharmaceuticals Co., Ltd.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: EO9(Apaziquone) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| 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) |
Resource links provided by NLM:
Further study details as provided by Handok Pharmaceuticals Co., Ltd.:
Primary Outcome Measures:
- Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 11 |
| Study Start Date: | May 2011 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: EO9(Apaziquone)
immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Handok Pharmaceuticals Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01373398 History of Changes |
| Other Study ID Numbers: | HD901_01 |
| Study First Received: | June 9, 2011 |
| Last Updated: | March 12, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Handok Pharmaceuticals Co., Ltd.:
|
bladder cancer EO9 Apaziquone |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases |
Urologic Diseases Apaziquone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013