A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

August 29, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2026

Conditions
Bladder CancerUrothelial CarcinomaUrothelial Carcinoma Bladder
Interventions
DRUG

UGN-103

UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

Trial Locations (14)

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10941

RECRUITING

Crystal Run Healthcare, Middletown

11501

RECRUITING

Perlmutter Cancer Center at NYU Langone Hospital - Long Island, New York

11530

RECRUITING

AccuMed Research Associates, Garden City

14225

RECRUITING

Great Lakes Physician dba WNYU, Cheektowaga

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

30127

RECRUITING

Peachtree Clinical Solutions, Powder Springs

46202

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

77027

RECRUITING

Houston Metro Urology (HMU) - Southwest Location, Houston

77030

RECRUITING

Houston Methodist Hospital, Houston

92123

RECRUITING

Genesis Research, LLC, San Diego

99202

RECRUITING

Spokane Urology, P.S., Spokane

07962

RECRUITING

Garden State Urology, Morristown

37209-4035

RECRUITING

Urology Associates P.C. - Nashville, Nashville

All Listed Sponsors
lead

UroGen Pharma Ltd.

INDUSTRY