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1 Study Matches

Site for A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence

This Phase 3, multinational, single-arm, multicenter study will evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with LG IR NMIBC.

Administered locally via standard catheters, UGN-102 is designed to fill and conform to the anatomy of the bladder and dwell for a period of several hours before being excreted via normal urine flow.

Jay Raman

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Low Grade Bladder Cancer
Requiring treatment with TURBT
Multiple tumors
Tumor >3cm
Tumor recurrence within 1 year

Exclusion Criteria:
Received BCG within previous 1 year
History of High Grade bladder Cancer in past 2 years
Sensitivity to mitomycin
Neurogenic bladder
Significant urethral stricture precluding passage of urethral catheter
Approved drug(s)
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Location Contacts
Hershey, PA ,