This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter, all of which must have been fully resected at TURBT.~In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.~Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio :~Arm 1 : One Dose of Apaziquone:~Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT~Day 15 (±5 days): administration of placebo~Arm 2 : Two Doses of Apaziquone :~Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT~Day 15 (±5 days): administration of 4 mg of apaziquone~Arm 3: Placebo :~Day 1 : administration of placebo 60±30 minutes post-TURBT~Day 15 (±5 days) : administration of placebo~Once randomized, Day 1 study drug instillation occurred 60 ±30 minutes post TURBT. Participants returned on Day 15 (±5 days) for a second instillation unless their pathology results showed non Ta, G1-G2 histology; in the absence of local pathology results by the Day 15 visit, participants received a second instillation of study drug. All histology specimens were reviewed by a local pathology laboratory and all clinical treatment decisions and study analyses were based on the local pathology review. Participants whose pathology was other than Ta, G1-G2 were followed for safety at Day 35 (±5 days) from the last dose of study drug and then discontinued from the study.~Participants with pathology confirmed Ta, G1-G2 disease were followed according to the schedule below :~Cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through 24 months for tumor recurrence and progression.~If at any time during the 24 months follow up period there was a tumor recurrence, the participant continued on study with follow-up cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months. Participants with a recurrence were permitted to have a follow-up TURBT.~If at any time during the 24 months follow up period there was a tumor recurrence and/or participant started on another therapy, the participant was followed by telephone, for safety every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months.~Duration of Study: The duration of the study for each participant was approximately 24 months including:~Screening Period : 30-days~Treatment Period : Day 1 and Day 15 (±5 days)~Safety and Follow-up Period: 24-months
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT.~In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.~Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio.~Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.