The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder. A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3). * If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). * If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). All patients were to be followed for 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
802
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
A single intravesical dose of placebo instilled into the bladder post-TURBT
TransUrethral Resection of the Bladder Tumor
Recurrence Rate at 2 Years
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
Time frame: 2 years
Time to Recurrence
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Time frame: 2 years
Progression Rate at 2 Years
The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.
Time frame: 2 years
Time to Progression
The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
Time frame: 2 years
Number of Recurrences Per Patient
The number of histologically confirmed recurrences during the course of the study.
Time frame: 2 years
Disease Free Interval
The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Time frame: 2 years
Disease Free Survival
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Time frame: 2 years
Overall Survival
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Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
BCG Oncology
Phoenix, Arizona, United States
Sun Health Research Institute
Sun City, Arizona, United States
Urology Associates Medical Group
Burbank, California, United States
Urology Associates of Central CA
Fresno, California, United States
South Orange County Medical Research Center
Laguna Woods, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cancer Research Dept/St. Joseph Hospital
Orange, California, United States
San Bernardino Urologic Association
San Bernardino, California, United States
VA Medical Center
San Francisco, California, United States
...and 64 more locations
The number of months from randomization to death from any cause.
Time frame: 2 years