Clinical trial · Interventional
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
NCT01475266CI-TRIAL-00026686terminatedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EO9 (Apaziquone) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EO9 (Apaziquone)
- interventionNames
- Drug: EO9 (Apaziquone)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
- timeFrame
- 2 years
Secondary outcomes (7)
- measure
- The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who have provided written informed consent 2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria: * The maximum number of tumors is 5. * Each tumor diameter: ≤ 3.5 cm. 3. Age: ≥20 years old at enrollment. 4. The functions of the major organs are adequate, and the following test value criteria are satisfied: * Neutrophil count ≥1,500/μL * Platelet count ≥10×10\^4/μL * Hemoglobin ≥10 g/dL Exclusion Criteria: 1. Patients with a single, primary bladder cancer of \<0.5 cm. 2. Patients with CIS lesions in the bladder or a history thereof. 3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease. 4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months). 5. Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening 6. Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof. 7. Patients who had been administered EO9 in the past. 8. Patients who had been administered any other investigational drug within the past 30 days. 9. Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.
References
Publications (0)
Data not yet available
No reference posted for this study.