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Protocol No. UW17039
Principal Investigator Downs, Tracy
Age Group Adult
Sponsor Type Industry
Title A Randomized, Multicenter, Two-ARM, Single-Dose, Double-Blind, Placebo-Controlled Phase 3 Study of Intravesical Qapzola (Apaziquone) as a Chemotherapy Adjuvant to TransUrethral Resection of Bladder Tumors in Patients with Low-to Intermedicate-Risk Non-Muscle Invasive Bladder Cancer (CONQUER)
Objective The primary purpose of the study is to gather information on an investigational study drug called apaziquone. If you choose to take part in this study, this study drug would be given to you after you have had bladder tumor surgery. Apaziquone (Qapzola) is an investigational, anti-cancer drug known as a bio-reductive alkylating indoloquinone which is thought to cause cell death. Early studies in humans have shown apaziquone has some anti-cancer activity that may prevent or delay the return of bladder cancer following surgery. The standard of care for bladder cancer is to surgically remove the tumors through surgery. This is known as a transurethral resection of bladder tumor (TURBT). However, bladder cancer often comes back, even after surgery. This study is to determine if giving apaziquone right after the surgery will decrease the risk of the cancer coming back.
Treatment One dose of either Qapzola or placebo(a substance that has no therapeutic effect) will be administered into the bladder after the transurethral resection of bladder tumor(TURBT) is completed and this will be instilled through an indwelling foley catheter and will be retained in the bladder for 60 minutes.
Description A Randomized, Multicenter, Two-Arm, Single-Dose, Double-Blind, Placebo-Controlled Phase 3 Study of Intravesical Qapzol (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients with Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Patient must have a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer
Patient is at least 18 years of age and <90 years of age
Patients of childbearing potential must be willing to use two forms of contraception
No prior malignancy within the last 5 years
No prior pelvic radiotherapy (including external beam and/or brachytherapy).
No history of allergy to red color food dye
No active uncontrolled infection
Must have adequate bone marrow function
No previous confirmed extravesical urothelial disease (upper tract and urethral including prostatic urethral)
No prior intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the last 3 years
No tumor in the bladder diverticulum
No history of interstitial cystitis
Can not be pregnant or breast feeding
Applicable Disease Sites Bladder
Participating Institutions UW Hospital and Clinics