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Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)


Phase 1
20 Years
74 Years
Not Enrolling
Both
Bladder Cancer

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Trial Information

Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)

Outcome Time Frame:

14 weeks

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

HD901_01

NCT ID:

NCT01373398

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • EO9
  • Apaziquone
  • Urinary Bladder Neoplasms

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