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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04688931
Other study ID # BL006
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 19, 2021
Est. completion date March 17, 2023

Study information

Verified date May 2024
Source UroGen Pharma Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This global, randomized, controlled, open-label Phase 3 study was 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).


Description:

Eligible patients were randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization was stratified by the presence of a previous LG-NMIBC episode within 1 year of the current diagnosis (yes or no). Starting on 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 underwent TURBT. All patients returned to the clinic approximately 3 months after the start of treatment for a disease assessment visit. Response to treatment was determined based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions, and voiding urine cytology. Patients confirmed to have a complete response (CR), defined as having no detectable disease (NDD) in the bladder, received no further treatment and entered the Follow-up Period of the study. Patients confirmed to have a non-complete response (NCR) due to residual LG disease in either treatment arm underwent TURBT of any remaining lesions and then entered the Follow-up Period of the study. During the Follow-up Period, patients returned to the clinic every 3 months to determine if they remained disease free. Patients remained on study until completion of all follow-up visits or until disease recurrence, disease progression, or death was documented, whichever occurred first. Patients determined to have a protocol-defined recurrence or progression at any follow-up or unscheduled visit were 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.


Recruitment information / eligibility

Status Terminated
Enrollment 282
Est. completion date March 17, 2023
Est. primary completion date March 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. Patient who has newly diagnosed or historic LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks of Screening. 3. 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). 4. Negative voiding cytology for HG disease within 6 weeks of Screening. 5. 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. 6. Has no evidence of active urinary tract infection (UTI). 7. 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: 1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment. 2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year. 3. History of HG papillary UC in the past 2 years. 4. Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed. 5. Clinically significant urethral stricture that would preclude passage of a urethral catheter. 6. History of pelvic radiotherapy. 7. History of: - Neurogenic bladder; - Active urinary retention; - Any other condition that would prohibit normal voiding. 8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC. 9. Current tumor stage of T1. 10. 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. 11. History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately after any previous TURBT. 12. Has previously participated in a study in which they received UGN-102. 13. Has participated in a study with an investigational agent or device within 30 days of randomization.

Study Design


Intervention

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.
Procedure:
TURBT
The current standard of care for treatment of LG-IR-NMIBC is TURBT under general anesthesia.

Locations

Country Name City State
Bulgaria Multiprofile Hospital for Active Treatment "Puls", Department of Urology Blagoevgrad
Bulgaria Multiprofile Hospital for Active Treatment - Blagoevgrad Blagoevgrad
Bulgaria Complex Oncology Center - Burgas Burgas
Bulgaria Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology Gabrovo
Bulgaria Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom Lom
Bulgaria Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi" Montana
Bulgaria University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic Pleven
Bulgaria University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology Pleven
Bulgaria Multiprofile Hospital for Active Treatment Park Hospital Plovdiv
Bulgaria University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology Plovdiv
Bulgaria University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology Plovdiv
Bulgaria University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology Ruse
Bulgaria Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology Shumen
Bulgaria University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic Sofia
Bulgaria University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic Sofia
Bulgaria Multiprofile Hospital for Active Treatment - Targovishte Targovishte
Bulgaria Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic Varna
Bulgaria Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology Varna
Bulgaria University Multiprofile Hospital for Active Treatment "Sveta Marina" Varna
Bulgaria Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology Veliko Tarnovo
Bulgaria First Private Hospital Vratsa, Department of Urology Vratsa
Bulgaria Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology Yambol
Estonia East Viru Central Hospital, Surgery Clinic Kohtla-Järve
Estonia East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology Tallinn
Estonia North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre Tallinn
Estonia West Tallinn Central Hospital Ltd., Department of Urology Tallinn
Estonia Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation Tartu
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 Central University Clinic After Academic N. Kipshidze 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
Israel Edith Wolfson Medical Center H_olon
Israel Lady Davis Carmel Medical Center Haifa
Israel Rambam Health Care Campus Haifa
Israel Rabin Medical Center Petah tikva
Israel Chaim Sheba Medical Center Ramat Gan
Latvia Liepajas Regional Hospital, Urology Department Liepaja
Latvia Daugavpils Regional Hospital, Urology Department Riga
Latvia LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology Riga
Latvia P. Stradins Clinical University Hospital, Center for Urology Riga
Poland Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology Bydgoszcz
Poland AKMED Gliwice
Poland Prof.E Michalowski Specialist Hospital Katowice
Poland SCM sp. z o.o. (LLC) Kraków
Poland "City Clinic" Limited Liability Company Warsaw
Poland Miedzyleski Specialist Hospital in Warsaw, Department of Urology Warsaw
Russian Federation Sverdlovsk Regional Clinical Hospital #1 Ekaterinburg
Russian Federation Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center Krasnoyarsk
Russian Federation D.D. Pletnyov City Clinical Hospital, Department of Oncourology Moscow
Russian Federation Moscow City Oncology Hospital #62 Moscow
Russian Federation Murmansk Bayandin Regional Clinical Hospital Murmansk
Russian Federation Privolzhsky Regional Medical Center, Urology Department Nizhny Novgorod
Russian Federation Tsyb Medical Radiology Research Center, Oncourology Department Obninsk
Russian Federation Clinical Oncology Center, Department of Urology and Oncology Omsk
Russian Federation N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology Penza
Russian Federation Pyatigorsk City Clinical Hospital, Department of Urology Pyatigorsk
Russian Federation A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology Saint Petersburg
Russian Federation Aleksandrovskaya City Hospital, Department of Urology Saint Petersburg
Russian Federation City Hospital #15, Urology Department #12 Saint Petersburg
Russian Federation First I.P. Pavlov State Medical University of St. Petersburg Saint Petersburg
Russian Federation I.I. Mechnikov North-Western State Medical University, Department of Urology Saint Petersburg
Russian Federation Leningrad Regional Clinical Oncology Center, Department of Chemotherapy Saint Petersburg
Russian Federation Medical and Sanitary Unit #70 of "Passazhiravtotrans" Saint Petersburg
Russian Federation N.N. Petrov National Medical Research Center of Oncology, Oncourology Department Saint Petersburg
Russian Federation Railway Clinical Hospital under OAO Russian Railways Saint Petersburg
Russian Federation St. Luka Clinical Hospital, Department of Urology Saint Petersburg
Russian Federation St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology Saint Petersburg
Russian Federation St.-Petersburg Scientific Research Institute of Phthisiopulmonology Saint Petersburg
Russian Federation Siberian State Medical University Tomsk
Russian Federation Regional Oncology Center, Tyumen, Oncology Department Tyumen
Russian Federation Republican Clinical Oncology Center Ufa
Russian Federation Volgograd Regional Center for Urology and Nephrology, Urology Department Volzhskiy
Russian Federation Medical Center for Diagnostics and Prevention Plus Yaroslavl
Serbia Clinical Center of Serbia, Clinic of Urology Belgrade
Serbia Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology Belgrade
Serbia Clinical Hospital Center Zemun, Urology unit Belgrade
Serbia Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis Kragujevac
Ukraine Chernihiv Medical Center of Modern Oncology Chernihiv
Ukraine Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital Chernivtsi
Ukraine Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department Chernivtsi
Ukraine Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2 Dnipro
Ukraine Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care Dnipro
Ukraine Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology Dnipro
Ukraine Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council Ivano-Frankivs'k
Ukraine Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology Ivano-Frankivs'k
Ukraine Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology Kharkiv
Ukraine Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery Kharkiv
Ukraine Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5 Kharkiv
Ukraine Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary" Kherson
Ukraine State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine Kyiv
Ukraine Volyn Regional Medical Oncology Centre Luts'k
Ukraine Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology Lviv
Ukraine Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology Lviv
Ukraine Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center Lviv
Ukraine Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology Odesa
Ukraine Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council Odesa
Ukraine Sumy Regional Clinical Oncology Center Sumy
Ukraine Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy Ternopil'
Ukraine Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council Uzhhorod
Ukraine Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council" Vinnytsia
Ukraine Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology Zaporizhia
United States Albany Medical Center Albany New York
United States Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology Bala-Cynwyd Pennsylvania
United States Chesapeake Urology Research Associates Baltimore Maryland
United States New Jersey Urology Bloomfield New Jersey
United States UNC Chapel Hill Memorial Hospital Chapel Hill North Carolina
United States Great Lakes Physician dba WNY Urology Associates Cheektowaga New York
United States University of Chicago Hospital Chicago Illinois
United States University of Texas Southwestern Medical Center Dallas Texas
United States New Jersey Urology Englewood New Jersey
United States AccuMed Research Associates Garden City New York
United States Chesapeake Urology Research Associates Hanover Maryland
United States Penn State Health Milton S. Hershey Medical Center and College of Medicine Hershey Pennsylvania
United States First Urology, PSC Jeffersonville Indiana
United States Comprehensive Urologic Care Lake Barrington Illinois
United States Urology Center Las Vegas Nevada
United States Loma Linda University Medical Center Loma Linda California
United States Urology Group of Southern California Los Angeles California
United States Clinical Research Solutions Middleburg Heights Ohio
United States Garden State Urology Morristown New Jersey
United States Carolina Urologic Research Center Myrtle Beach South Carolina
United States Manhattan Medical Research New York New York
United States Adult & Pediatric Urology, PC Omaha Nebraska
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Urology San Antonio San Antonio Texas
United States San Diego Clinical Trials San Diego California
United States Providence Saint John's Health Center Santa Monica California
United States Skyline Urology Sherman Oaks California
United States Regional Urology, LLC Shreveport Louisiana
United States Stony Brook Cancer Center Stony Brook New York
United States Associated Medical Professionals of NY, PLLC Syracuse New York
United States Arizona Institute of Urology, PLLC Tucson Arizona
United States Wichita Urology Group Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
UroGen Pharma Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Estonia,  Georgia,  Israel,  Latvia,  Poland,  Russian Federation,  Serbia,  Ukraine, 

References & Publications (1)

Prasad SM, Huang WC, Shore ND, Hu B, Bjurlin M, Brown G, Genov P, Shishkov D, Khuskivadze A, Ganev T, Marchev D, Orlov I, Kopyltsov E, Zubarev V, Nosov A, Komlev D, Burger B, Raju S, Meads A, Schoenberg M. Treatment of Low-grade Intermediate-risk Nonmuscl — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free Survival (DFS) DFS is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), progression to high-grade (HG) disease, or death due to any cause. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization. 15 months
Secondary Time to Recurrence (TTR) TTR is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), or progression to HG disease. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization. 15 months
Secondary Complete Response Rate (CRR) CRR is defined as the percentage of patients who achieve CR at the 3-month Visit. 3 months
Secondary Duration of Response (DOR) DOR is defined as the time from first documented CR until the earliest date of recurrence of LG disease, progression to HG disease, or death due to any cause. DOR applies only to patients who achieve CR at the 3-month Visit. Summarized is the Kaplan-Meier estimated probability of remaining in response at 12 months after 3-month CR. 12 months
Secondary Observed CRR at Scheduled Disease Assessment Time Points Observed CRR at scheduled disease assessment time points is defined as the percentage of patients who achieve CR at the 3-month Visit and maintain CR up to a particular follow-up visit. Summarized is the observed percentage of patients remaining in response at 3, 6, 9, and 12 months after 3-month CR. 12 months
Secondary Number of TURBTs Number of TURBTs is defined as the average number of per protocol TURBTs per patient in each arm. Per protocol TURBTs are defined as the Day 1 TURBT for patients in the TURBT alone arm and TURBT due to residual LG disease at the 3-month disease assessment in either arm. 3 months
Secondary Changes From Baseline in Health-related Quality of Life The European Organisation for Research and Treatment of Cancer (EORTC) 24-item quality of life questionnaire for patients with NMIBC (QLQ-NMIBC24) is a patient-reported instrument that assesses 11 domains (urinary symptoms, malaise, future worries, bloating and flatulence, intravesical treatment issues, sexual intimacy, risk of contaminating partner, male sexual problems, female sexual problems, sexual function, and sexual enjoyment).
All of the domains range in score from 0 to 100 with lower scores reflecting better functioning/quality of life and higher scores reflecting worse functioning/quality of life.
Summarized is the change from baseline in domain scores at the 3-month Visit. Changes in domain scores were calculated for patients with non-missing answers at both time points.
Pre-treatment to 3 months after the start of treatment
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest The number of patients with each type of event will be summarized. TEAEs were defined as adverse events (AEs) that occurred on or after the day of first instillation of UGN-102 for patients in the UGN-102 ± TURBT arm or the day of initial TURBT for patients in the TURBT alone arm, or pre-treatment events that worsened during the study. Up to 21 months
Secondary Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values The number of patients with each type of event will be summarized. Up to 6 months
Secondary Number of Participants With Post-baseline PCS Serum Chemistry Values The number of patients with each type of event will be summarized. Up to 6 months
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