Bladder Cancer Clinical Trial

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

Summary

This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).

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Full Description

Eligible patients will be randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 ± TURBT arm will receive 6 weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone arm will undergo TURBT.

Patients in both treatment arms will return to the clinic at approximately 3 months after the start of treatment to determine response to treatment. Patients confirmed to have a complete response (CR) will receive no further treatment and will enter the Follow-up Period of the study. Patients confirmed to have a non-complete response (NCR) will undergo TURBT of any remaining lesions and then enter the Follow-up Period of the study.

During the Follow-up Period, patients will return to the clinic every 3 months to determine durability of response. Patients will remain on study until completion of all follow-up visits or until disease recurrence, disease progression, or death is documented, whichever occurs first. Patients determined to have a protocol-defined recurrence or progression at any follow-up or unscheduled visit will be considered to have completed the study and released to the care of their treating physician.

Study enrollment was stopped early by the sponsor to pursue an alternative development strategy for UGN-102 in the treatment of bladder cancer. Patients who had consented at the time the trial terminated were permitted to continue, but follow-up was terminated once the last patient had been followed for 15 months after the start of treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks of Screening.

Has intermediate risk disease, defined as having 1 or 2 of the following:

Presence of multiple tumors;
Solitary tumor > 3 cm;
Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
Negative voiding cytology for high grade (HG) disease within 6 weeks of Screening.

Has adequate organ and bone marrow function as determined by the following routine laboratory tests:

Leukocytes ≥ 3,000 cells per μL;
Absolute neutrophil count ≥ 1,500 cells per μL;
Platelets ≥ 100,000 per μL;
Hemoglobin ≥ 9.0 g/dL;
Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
Has no evidence of active urinary tract infection (UTI).
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.

Exclusion Criteria:

History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
History of HG papillary UC in the past 2 years.
Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
Clinically significant urethral stricture that would preclude passage of a urethral catheter.
History of pelvic radiotherapy.

History of:

Neurogenic bladder;
Active urinary retention;
Any other condition that would prohibit normal voiding.
Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC.
Current tumor grading of T1.
Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.
History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately after any previous TURBT.
Has previously participated in a study in which they received UGN-102.
Has participated in a study with an investigational agent or device within 30 days of randomization.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

282

Study ID:

NCT04688931

Recruitment Status:

Terminated

Sponsor:

UroGen Pharma Ltd.

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There are 126 Locations for this study

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Arizona Institute of Urology, PLLC
Tucson Arizona, 85704, United States
Loma Linda University Medical Center
Loma Linda California, 92350, United States
Urology Group of Southern California
Los Angeles California, 90017, United States
San Diego Clinical Trials
San Diego California, 92120, United States
Providence Saint John's Health Center
Santa Monica California, 90404, United States
Skyline Urology
Sherman Oaks California, 91411, United States
University of Chicago Hospital
Chicago Illinois, 60637, United States
Comprehensive Urologic Care
Lake Barrington Illinois, 60010, United States
First Urology, PSC
Jeffersonville Indiana, 47130, United States
Wichita Urology Group
Wichita Kansas, 67226, United States
Regional Urology, LLC
Shreveport Louisiana, 71106, United States
Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States
Adult & Pediatric Urology, PC
Omaha Nebraska, 68114, United States
Urology Center
Las Vegas Nevada, 89144, United States
New Jersey Urology
Bloomfield New Jersey, 07003, United States
New Jersey Urology
Englewood New Jersey, 07631, United States
Garden State Urology
Morristown New Jersey, 07960, United States
Albany Medical Center
Albany New York, 12208, United States
Great Lakes Physician dba WNY Urology Associates
Cheektowaga New York, 14225, United States
AccuMed Research Associates
Garden City New York, 11530, United States
Manhattan Medical Research
New York New York, 10016, United States
Stony Brook Cancer Center
Stony Brook New York, 11794, United States
Associated Medical Professionals of NY, PLLC
Syracuse New York, 13210, United States
UNC Chapel Hill Memorial Hospital
Chapel Hill North Carolina, 27599, United States
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Penn State Health Milton S. Hershey Medical Center and College of Medicine
Hershey Pennsylvania, 17033, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh
Pittsburgh Pennsylvania, 15237, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Urology San Antonio
San Antonio Texas, 78229, United States
Multiprofile Hospital for Active Treatment "Puls", Department of Urology
Blagoevgrad , 2700, Bulgaria
Multiprofile Hospital for Active Treatment - Blagoevgrad
Blagoevgrad , 2700, Bulgaria
Complex Oncology Center - Burgas
Burgas , 8000, Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo , 5300, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
Lom , 3600, Bulgaria
Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
Montana , 3400, Bulgaria
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
Pleven , 5800, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
Pleven , 5800, Bulgaria
Multiprofile Hospital for Active Treatment Park Hospital
Plovdiv , 4000, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology
Plovdiv , 4002, Bulgaria
University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology
Plovdiv , 4003, Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Ruse , 7000, Bulgaria
Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
Shumen , 9700, Bulgaria
University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic
Sofia , 1431, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
Sofia , 1606, Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte
Targovishte , 7700, Bulgaria
Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
Varna , 9000, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
Varna , 9002, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna , 9010, Bulgaria
Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
Veliko Tarnovo , 5000, Bulgaria
First Private Hospital Vratsa, Department of Urology
Vratsa , 3001, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
Yambol , 8600, Bulgaria
East Viru Central Hospital, Surgery Clinic
Kohtla-Järve , 31025, Estonia
East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
Tallinn , 10138, Estonia
West Tallinn Central Hospital Ltd., Department of Urology
Tallinn , 10617, Estonia
North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
Tallinn , 13419, Estonia
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu , 50406, Estonia
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi , 0160, Georgia
JSC Jerarsi, Department of Urology
Tbilisi , , Georgia
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
Tbilisi , , Georgia
LTD Gidmedi, Urology Department
Tbilisi , , Georgia
LTD L. Managadze National Center of Urology, Department of Urology
Tbilisi , , Georgia
LTD MMT Hospital, Urology Department
Tbilisi , , Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology
Tbilisi , , Georgia
Pineo Medical Ecosystem Ltd., Department of Urology
Tbilisi , , Georgia
Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
Tbilisi , , Georgia
Rambam Health Care Campus
Haifa , 31096, Israel
Lady Davis Carmel Medical Center
Haifa , 34362, Israel
Edith Wolfson Medical Center
H̱olon , 58100, Israel
Rabin Medical Center
Petah tikva , 49100, Israel
Chaim Sheba Medical Center
Ramat Gan , 52620, Israel
Liepajas Regional Hospital, Urology Department
Liepāja , LV-34, Latvia
P. Stradins Clinical University Hospital, Center for Urology
Riga , LV-10, Latvia
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga , LV-10, Latvia
Daugavpils Regional Hospital, Urology Department
Riga , LV-54, Latvia
Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology
Bydgoszcz , 85-16, Poland
AKMED
Gliwice , 44-10, Poland
Prof.E Michalowski Specialist Hospital
Katowice , 40-07, Poland
SCM sp. z o.o. (LLC)
Kraków , 31-55, Poland
"City Clinic" Limited Liability Company
Warsaw , 02-47, Poland
Miedzyleski Specialist Hospital in Warsaw, Department of Urology
Warsaw , 04-74, Poland
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg , 62010, Russian Federation
Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
Krasnoyarsk , 66013, Russian Federation
D.D. Pletnyov City Clinical Hospital, Department of Oncourology
Moscow , 10507, Russian Federation
Moscow City Oncology Hospital #62
Moscow , 12513, Russian Federation
Murmansk Bayandin Regional Clinical Hospital
Murmansk , 18304, Russian Federation
Privolzhsky Regional Medical Center, Urology Department
Nizhny Novgorod , 60300, Russian Federation
Tsyb Medical Radiology Research Center, Oncourology Department
Obninsk , 24903, Russian Federation
Clinical Oncology Center, Department of Urology and Oncology
Omsk , 64401, Russian Federation
N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology
Penza , 44002, Russian Federation
Pyatigorsk City Clinical Hospital, Department of Urology
Pyatigorsk , 35750, Russian Federation
Leningrad Regional Clinical Oncology Center, Department of Chemotherapy
Saint Petersburg , 18866, Russian Federation
Aleksandrovskaya City Hospital, Department of Urology
Saint Petersburg , 19331, Russian Federation
St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology
Saint Petersburg , 19401, Russian Federation
A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology
Saint Petersburg , 19404, Russian Federation
St. Luka Clinical Hospital, Department of Urology
Saint Petersburg , 19404, Russian Federation
St.-Petersburg Scientific Research Institute of Phthisiopulmonology
Saint Petersburg , 19406, Russian Federation
Medical and Sanitary Unit #70 of "Passazhiravtotrans"
Saint Petersburg , 19500, Russian Federation
I.I. Mechnikov North-Western State Medical University, Department of Urology
Saint Petersburg , 19506, Russian Federation
Railway Clinical Hospital under OAO Russian Railways
Saint Petersburg , 19527, Russian Federation
First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg , 19702, Russian Federation
N.N. Petrov National Medical Research Center of Oncology, Oncourology Department
Saint Petersburg , 19775, Russian Federation
City Hospital #15, Urology Department #12
Saint Petersburg , 19820, Russian Federation
Siberian State Medical University
Tomsk , 63405, Russian Federation
Regional Oncology Center, Tyumen, Oncology Department
Tyumen , 62504, Russian Federation
Republican Clinical Oncology Center
Ufa , 45005, Russian Federation
Volgograd Regional Center for Urology and Nephrology, Urology Department
Volzhskiy , 40412, Russian Federation
Medical Center for Diagnostics and Prevention Plus
Yaroslavl , 15004, Russian Federation
Clinical Center of Serbia, Clinic of Urology
Belgrade , 11000, Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
Belgrade , 11080, Serbia
Clinical Hospital Center Zemun, Urology unit
Belgrade , 11080, Serbia
Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
Kragujevac , 34000, Serbia
Chernihiv Medical Center of Modern Oncology
Chernihiv , 14029, Ukraine
Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital
Chernivtsi , 58001, Ukraine
Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department
Chernivtsi , 58023, Ukraine
Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2
Dnipro , 49005, Ukraine
Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology
Dnipro , 49074, Ukraine
Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care
Dnipro , 49102, Ukraine
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology
Ivano-Frankivs'k , 76008, Ukraine
Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council
Ivano-Frankivs'k , 76018, Ukraine
Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5
Kharkiv , 61037, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology
Kharkiv , 61070, Ukraine
Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery
Kharkiv , 61166, Ukraine
Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"
Kherson , 73000, Ukraine
State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine
Kyiv , 04053, Ukraine
Volyn Regional Medical Oncology Centre
Luts'k , 43018, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology
Lviv , 79010, Ukraine
Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center
Lviv , 79031, Ukraine
Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology
Lviv , 79059, Ukraine
Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
Odesa , 65025, Ukraine
Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology
Odesa , 65074, Ukraine
Sumy Regional Clinical Oncology Center
Sumy , 40022, Ukraine
Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy
Ternopil' , 46023, Ukraine
Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council
Uzhhorod , 88014, Ukraine
Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"
Vinnytsia , 21029, Ukraine
Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology
Zaporizhia , 69600, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

282

Study ID:

NCT04688931

Recruitment Status:

Terminated

Sponsor:


UroGen Pharma Ltd.

How clear is this clinincal trial information?

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