Bladder Cancer Clinical Trial
— ATLASOfficial title:
A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
Verified date | May 2024 |
Source | UroGen Pharma Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
UroGen Pharma Ltd. |
United States, Bulgaria, Estonia, Georgia, Israel, Latvia, Poland, Russian Federation, Serbia, Ukraine,
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
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 |
Status | Clinical Trial | Phase | |
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