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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01475266

Enrollment

Registered

2011-11-21

Start date

2011-11-30

Completion date

2013-04-30

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder Cancer, NMIBC, TURBT, Apaziquone, EOquin, Immediate instillation

Brief summary

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.

Interventions

DRUGEO9 (Apaziquone)

4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

DRUGPlacebo

40 mL, Intravesical instillation, Single dose within 6 hours after TURBT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer	2 years

Secondary

Measure	Time frame
The progression rate	2 years
The number of recurrences per patient	2 years
The progression-free survival period	2 years
The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer	2 years
The overall survival period	2 years
The safety of EO9	2 years
The recurrence-free survival period	2 years

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026