Conditions: Bladder Cancer
Keywords: Noninvasive Bladder Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 812
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT arm 2: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT

Interventions: intervention 1: Apaziquone intervention 2: Placebo intervention 3: TURBT
Intervention descriptions: intervention 1: A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT intervention 2: A single intravesical dose of placebo instilled into the bladder post-TURBT intervention 3: TransUrethral Resection of the Bladder Tumor

Protocol document: