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

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)

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).

Study Overview

• Status: Terminated
• Conditions: Bladder Cancer; Urothelial Carcinoma Bladder; Urothelial Carcinoma
• Intervention / Treatment: Drug: UGN-102; Procedure: TURBT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment "Puls", Department of Urology
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment - Blagoevgrad
  • Burgas, Bulgaria, 8000
    • Complex Oncology Center - Burgas
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
  • Lom, Bulgaria, 3600
    • Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
  • Montana, Bulgaria, 3400
    • Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hospital for Active Treatment Park Hospital
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology
  • Plovdiv, Bulgaria, 4003
    • University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology
  • Ruse, Bulgaria, 7000
    • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
  • Shumen, Bulgaria, 9700
    • Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic
  • Sofia, Bulgaria, 1606
    • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
  • Targovishte, Bulgaria, 7700
    • Multiprofile Hospital for Active Treatment - Targovishte
  • Varna, Bulgaria, 9000
    • Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
  • Varna, Bulgaria, 9002
    • Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
  • Varna, Bulgaria, 9010
    • University Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Veliko Tarnovo, Bulgaria, 5000
    • Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
  • Vratsa, Bulgaria, 3001
    • First Private Hospital Vratsa, Department of Urology
  • Yambol, Bulgaria, 8600
    • Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
• Estonia
  • Kohtla-Järve, Estonia, 31025
    • East Viru Central Hospital, Surgery Clinic
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital Ltd., Department of Urology
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
  • Tartu, Estonia, 50406
    • Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
• Georgia
  • Tbilisi, Georgia, 0160
    • LTD Central University Clinic After Academic N. Kipshidze
  • Tbilisi, 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
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • H̱olon, Israel, 58100
    • Edith Wolfson Medical Center
  • Petah tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
• Latvia
  • Liepāja, Latvia, LV-3414
    • Liepajas Regional Hospital, Urology Department
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University Hospital, Center for Urology
  • Riga, Latvia, LV-1038
    • LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
  • Riga, Latvia, LV-5417
    • Daugavpils Regional Hospital, Urology Department
• Poland
  • Bydgoszcz, Poland, 85-168
    • Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology
  • Gliwice, Poland, 44-100
    • AKMED
  • Katowice, Poland, 40-073
    • Prof.E Michalowski Specialist Hospital
  • Kraków, Poland, 31-559
    • SCM sp. z o.o. (LLC)
  • Warsaw, Poland, 02-473
    • "City Clinic" Limited Liability Company
  • Warsaw, Poland, 04-749
    • Miedzyleski Specialist Hospital in Warsaw, Department of Urology
• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1
  • Krasnoyarsk, Russian Federation, 660133
    • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
  • Moscow, Russian Federation, 105077
    • D.D. Pletnyov City Clinical Hospital, Department of Oncourology
  • Moscow, Russian Federation, 125130
    • Moscow City Oncology Hospital #62
  • Murmansk, Russian Federation, 183047
    • Murmansk Bayandin Regional Clinical Hospital
  • Nizhny Novgorod, Russian Federation, 603001
    • Privolzhsky Regional Medical Center, Urology Department
  • Obninsk, Russian Federation, 249036
    • Tsyb Medical Radiology Research Center, Oncourology Department
  • Omsk, Russian Federation, 644013
    • Clinical Oncology Center, Department of Urology and Oncology
  • Penza, Russian Federation, 440026
    • N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology
  • Pyatigorsk, Russian Federation, 357500
    • Pyatigorsk City Clinical Hospital, Department of Urology
  • Saint Petersburg, Russian Federation, 188663
    • Leningrad Regional Clinical Oncology Center, Department of Chemotherapy
  • Saint Petersburg, Russian Federation, 193312
    • Aleksandrovskaya City Hospital, Department of Urology
  • Saint Petersburg, Russian Federation, 194017
    • St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology
  • Saint Petersburg, Russian Federation, 194044
    • A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology
  • Saint Petersburg, Russian Federation, 194044
    • St. Luka Clinical Hospital, Department of Urology
  • Saint Petersburg, Russian Federation, 194064
    • St.-Petersburg Scientific Research Institute of Phthisiopulmonology
  • Saint Petersburg, Russian Federation, 195009
    • Medical and Sanitary Unit #70 of "Passazhiravtotrans"
  • Saint Petersburg, Russian Federation, 195067
    • I.I. Mechnikov North-Western State Medical University, Department of Urology
  • Saint Petersburg, Russian Federation, 195271
    • Railway Clinical Hospital under OAO Russian Railways
  • Saint Petersburg, Russian Federation, 197022
    • First I.P. Pavlov State Medical University of St. Petersburg
  • Saint Petersburg, Russian Federation, 197758
    • N.N. Petrov National Medical Research Center of Oncology, Oncourology Department
  • Saint Petersburg, Russian Federation, 198205
    • City Hospital #15, Urology Department #12
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University
  • Tyumen, Russian Federation, 625041
    • Regional Oncology Center, Tyumen, Oncology Department
  • Ufa, Russian Federation, 450054
    • Republican Clinical Oncology Center
  • Volzhskiy, Russian Federation, 404120
    • Volgograd Regional Center for Urology and Nephrology, Urology Department
  • Yaroslavl, Russian Federation, 150040
    • Medical Center for Diagnostics and Prevention Plus
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center Of Serbia, Clinic of Urology
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Zemun, Urology unit
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
• Ukraine
  • Chernihiv, Ukraine, 14029
    • Chernihiv Medical Center of Modern Oncology
  • Chernivtsi, Ukraine, 58001
    • Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital
  • Chernivtsi, Ukraine, 58023
    • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department
  • Dnipro, Ukraine, 49005
    • Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2
  • Dnipro, Ukraine, 49074
    • Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology
  • Dnipro, Ukraine, 49102
    • Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care
  • Ivano-Frankivs'k, Ukraine, 76008
    • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology
  • Ivano-Frankivs'k, Ukraine, 76018
    • Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council
  • Kharkiv, Ukraine, 61037
    • Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5
  • Kharkiv, Ukraine, 61070
    • Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology
  • Kharkiv, Ukraine, 61166
    • Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery
  • Kherson, Ukraine, 73000
    • Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"
  • Kyiv, Ukraine, 04053
    • State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine
  • Luts'k, Ukraine, 43018
    • Volyn Regional Medical Oncology Centre
  • Lviv, Ukraine, 79010
    • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology
  • Lviv, Ukraine, 79031
    • Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center
  • Lviv, Ukraine, 79059
    • Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology
  • Odesa, Ukraine, 65025
    • Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
  • Odesa, Ukraine, 65074
    • Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology
  • Sumy, Ukraine, 40022
    • Sumy Regional Clinical Oncology Center
  • Ternopil', Ukraine, 46023
    • Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy
  • Uzhhorod, Ukraine, 88014
    • Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council
  • Vinnytsia, Ukraine, 21029
    • Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"
  • Zaporizhia, Ukraine, 69600
    • Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Institute of Urology, PLLC
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90017
      • Urology Group of Southern California
    • San Diego, California, United States, 92120
      • San Diego Clinical Trials
    • Santa Monica, California, United States, 90404
      • Providence Saint John's Health Center
    • Sherman Oaks, California, United States, 91411
      • Skyline Urology
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital
    • Lake Barrington, Illinois, United States, 60010
      • Comprehensive Urologic Care
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Wichita Urology Group
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Research Associates
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Urology Center
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • New Jersey Urology
    • Englewood, New Jersey, United States, 07631
      • New Jersey Urology
    • Morristown, New Jersey, United States, 07960
      • Garden State Urology
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Cheektowaga, New York, United States, 14225
      • Great Lakes Physician dba WNY Urology Associates
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10016
      • Manhattan Medical Research
    • Stony Brook, New York, United States, 11794
      • Stony Brook Cancer Center
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of NY, PLLC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill Memorial Hospital
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center and College of Medicine
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15237
      • University of Pittsburgh
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 high grade (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 grading 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UGN-102 ± TURBT; 6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients who have a NCR at the 3-month Visit (3 months after the start of treatment with UGN-102).	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.; Other Names: UGN-102 (mitomycin) for intravesical solution; Procedure: TURBT; The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.; Other Names: Transurethral resection of bladder tumors
Active Comparator: TURBT Alone; TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month Visit (3 months after the initial TURBT).	Procedure: TURBT; The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.; Other Names: Transurethral resection of bladder tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 HG disease, or death due to any cause.	Up to 21 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 21 months
Complete response rate (CRR)	CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.	3 months
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.	Up to 18 months
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.	Up to 21 months
Incidence of TURBT	Incidence of TURBT is defined as the percentage of patients requiring TURBT and the average number of TURBTs per patient in each treatment arm.	3 months
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). Descriptive statistics will be used to summarize the scored scales for each of the domains and the change from baseline in the domain scores at each scheduled assessment time point.	Up to 21 months
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology, serum chemistry, and urinalysis).	The percentage of patients with each type of event will be summarized.	Up to 21 months

Collaborators and Investigators

• Sponsor: UroGen Pharma Ltd.
• Investigators: Principal Investigator: Sandip Prasad, MD, Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: NMIBC; Non-muscle invasive bladder cancer; TURBT; Mitomycin; Low grade non-muscle invasive bladder cancer; Intermediate risk non-muscle invasive bladder cancer; UGN-102; Transurethral resection of bladder tumors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: BL006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No