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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT02563561

Run by

Spectrum Pharmaceuticals, Inc

People needed

62

Starts

2015-10-09

Expected to finish

2017-03-10

Last updated by the study team

2021-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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
• Upper tract Transitional Cell Carcinoma (TCC).
• Urethral tumor (prostatic urethra included).
• Any invasive bladder tumor known to be other than tumor Ta, G1-G2.
• Any evidence of lymph node or distant metastasis.
• Any bladder tumor with histology other than TCC.
• Carcinoma in situ (CIS).
• Participant had a tumor in a bladder diverticulum.
• Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy.)
• Participant had a bleeding disorder or a screening platelet count <100×10\^9/L.
• Participant had screening hemoglobin <10 milligrams per deciliter (mg/dL).
• Participant had any unstable medical condition that would make it unsafe to undergo TURBT.
• Participant had a history of interstitial cystitis.
• Participant had a history of allergy to red color food dye.
• For a participant with a recurrent tumor, the participant had at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
• Participant was pregnant or breast-feeding.

Where it is running

• The Urology Center of Colorado — Denver, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.