Clinical trial · Interventional
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
NCT01373398CI-TRIAL-00006458completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EO9(Apaziquone) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)
- timeFrame
- 14 weeks
Secondary outcomes (1)
- measure
- pharmacokinetics assessment of EO9 and it's metabolites in blood and urine
- timeFrame
- before, 30, 55, 90 mins of EO9 instillation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.