A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

October 15, 2018

Primary Completion Date

January 3, 2020

Study Completion Date

October 21, 2020

Conditions
Bladder CancerUrothelial CarcinomaUrothelial Carcinoma Bladder
Interventions
DRUG

UGN-102

"UGN-102 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-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.~The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL)."

Trial Locations (19)

10016

Manhattan Medical Research, New York

10065

Weill Cornell Medical College, New York

10461

Montefiore Medical Center (Albert Einstein), New York

14225

Western New York Urology Associates, New York

17033

Penn State Hershey State College, Hershey

21218

John Hopkins University, Baltimore

27572

The University of North Carolina, Chapel Hill

29572

Carolina Urologic Research Center, Myrtle Beach

33060

Clinical Research Center of Florida, Pompano Beach

37209

Urology Associates, PC, Nashville

49372

Rabin Medical Center, Petah Tikva

68114

Adult & Pediatric Urology, PC, Omaha

72211

Arkansas Urology, Little Rock

78233

Urology San Antonio, Fredericksburg

85054

Mayo Clinic Cancer Center, Phoenix

89144

Urology Las Vegas, Las Vegas

90404

Providence Medical Institute, Santa Monica

92350

Loma Linda University, Loma Linda

3436212

Carmel Medical Center, Haifa

All Listed Sponsors
lead

UroGen Pharma Ltd.

INDUSTRY

NCT03558503 - A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer | Biotech Hunter | Biotech Hunter