A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

April 26, 2023

Study Completion Date

February 29, 2028

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 under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

Trial Locations (65)

1090

Medical University Vienna, Department of Urology, Vienna

1527

"University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL, Sofia", Sofia

1606

"University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov, Sofia, Urology Clinic", Sofia

2700

Multiprofile Hospital for Active Treatment - Blagoevgrad, Blagoevgrad

3400

"Multiprofile Hospital for Active Treatment City Clinic - Sveti Georgi", Montana

3600

"Multiprofile Hospital for Active Treatment Sveti Nikolai Chudotvorets, Lom", Lom

4002

"University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv", Plovdiv

4003

University Multiprofile Hospital for Active Treatment, Plovdiv, Plovdiv

4109

Multiprofile Hospital for Active Treatment Park Hospital, Plovdiv

5300

"Multiprofile Hospital for Active Treatment Dr. Tota Venkova, Gabrovo, Department of Urology", Gabrovo

5800

"University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven, Urology Clinic", Pleven

"University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven, Department of Urology", Pleven

7000

University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology, Rousse

7700

Multiprofile Hospital for Active Treatment - Targovishte, Targovishte

8008

"Multiprofile Hospital for Active Treatment Life Hospital Burgas", Varna

8600

"Multiprofile Hospital for Active Treatment Sveti Pantaleymon, Yambol, Department of Urology", Yambol

9000

Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology, Varna

9002

"Multiprofile Hospital for Active Treatment Sveta Anna, Varna, Urology Clinic", Varna

9700

Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology, Shumen

10016

Manhattan Medical Research, New York

NYU Langone Health, New York

10029

Mount Sinai, New York

10138

East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology, Tallinn

10617

West Tallinn Central Hospital Ltd., Department of Urology, Tallinn

11000

Clinical Center of Serbia, Clinic of Urology, Belgrade

11080

Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology, Belgrade

Clinical Hospital Center Zemun, Urology unit, Belgrade

11530

AccuMed Research Associates, Garden City

13419

North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre, Tallinn

14225

Great Lakes Physician dba WNY Urology Associates, Cheektowaga

21076

Chesapeake Urology Research Associates, Hanover

21218

John Hopkins University, Baltimore

28040

University Hospital Foundation Jimenez Diaz, Madrid

28041

University Hospital 12 de Octubre, Madrid

28046

La Paz University Hospital, Madrid

31025

East Viru Central Hospital, Surgery Clinic, Kohtla-Järve

34000

Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis, Kragujevac

37209

Urology Associates, P.C., Nashville

48013

Hospital de Basurto, Bilbao

50406

Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation, Tartu

65212

University of Missouri, Columbia

67226

Wichita Urology Group, Wichita

77030

Houston Methodist Research Institute, Houston

85704

Arizona Urology Specialists, Tucson

92123

Genesis Research, San Diego

92350

Loma Linda University Medical Center, Loma Linda

99202

Spokane Urology, P.S., Spokane

07960

Atlantic Health System, Morristown

0160

LTD Central University Clinic After Academic N. Kipshidze, Tbilisi

Unknown

JSC Jerarsi, Department of Urology, Tbilisi

LTD Gidmedi, Urology Department, Tbilisi

Pineo Medical Ecosystem Ltd., Department of Urology, Tbilisi

Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department, Tbilisi

LV-3414

Liepajas Regional Hospital, Urology Department, Liepāja

LV-1002

P. Stradins Clinical University Hospital, Center for Urology, Riga

LV-1038

LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology, Riga

LV-5417

Daugavpils Regional Hospital, Urology Department, Riga

LT-50161

Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas

LT-92288

Klaipeda University Hospital, Klaipėda

08661

Vilnius University Hospital Santaros Klinikos, Vilnius

44-100

AKMED, Gliwice

31-559

SCM sp. z o.o. (LLC), Krakow

61-737

Clinical Research Center Limited liability company Medic-R Limited partnership, Poznan

05-135

Mazovian Oncology Hospital, Subdepartment of Urology, Wieliszew

08003

Hospital del Mar, Barcelona

All Listed Sponsors
lead

UroGen Pharma Ltd.

INDUSTRY