Urogen UGN-102 for Low-Grade NMIBC
Lay Title:A Study for the Treatment of Low Grade Bladder Cancer
Technical Title:A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence
Disease Type:Low Grade Non-Muscle Invasive Bladder Cancer (NMIBC)
Basic information:The purpose of this study is to evaluate the safety and effectiveness of UGN-102, an investigational gel which serves as a reservoir for prolonged drug release of a type of chemotherapy (Mitomycin C) locally in the bladder. Mitomycin C (MMC) is approved by the US Food and Drug Administration (FDA) for treating other types of cancer and is commercially available for the treatment of bladder cancer. UGN-102, a combination of MMC and gel, has not been approved by the FDA or other regulatory agencies and is not commercially available.
UGN-102 is intended to provide a new way to coat the inside of the bladder and keep the MMC in contact with the bladder wall for a longer time than when using MMC without the gel
Research Procedures (not a complete list):
You will receive 6 instillations (treatments) with UGN-102 into the bladder, once per week for 6 weeks. Approximately 5 weeks after your last instillation, you will have a study visit (your 3-month visit) to see if the treatments have been successful. If so, you will continue to receive UGN-102 treatments monthly, up to 8 monthly treatments, as long as you continue to have a successful response. You will undergo physical exams and blood and urine tests during your clinic visits. You will have up to 5 cystoscopy examinations, which is an examination that allows the doctor to see the inside of your urinary bladder. Some or all of these procedures would have been conducted even if you were not in this study.
Eligibility Criteria (not a complete list):
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