TerminatedPhase 3

A Study of Intravesical Apaziquone as a Surgical Adjuvant in Participant Undergoing Transurethral Resection Bladder Tumor (TURBT)

United States62 participantsStarted 2015-10-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Participant had an active concurrent malignancy/life-threatening disease. If there was a history of prior malignancies/life-threatening diseases, the participant was to be disease-free for at least 5 years. Participant with other prior malignancies less than 5 years before study entry could have still been enrolled if they had received treatment resulting in complete resolution of the cancer and currently had no clinical, radiologic, or laboratory evidence of active or recurrent disease.
✕. Participant had positive urine cytology for malignancy at Screening.
✕. Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
✕. Participant had used any investigational drugs, biologics, or devices within 30 days prior to study treatment or planned to use any of these during the course of the study.
✕. Participant had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
✕. Participant had or has ever had
✕. Participant had a tumor in a bladder diverticulum.
✕. Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy.)

What they're measuring

Time to Recurrence

Timeframe: From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years)

Trial details

NCT IDNCT02563561

SponsorSpectrum Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03-10

Results submitted2021-08-30

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