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

Primary Purpose

Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
UGN-102
TURBT
Sponsored by
UroGen Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Non-muscle invasive bladder cancer, Low grade non-muscle invasive bladder cancer, Intermediate risk non-muscle invasive bladder cancer, NMIBC, UGN-102, Mitomycin, Transurethral resection of bladder tumors, TURBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Is at intermediate risk for progression, 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 post 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.

Sites / Locations

  • Arizona Institute of Urology, PLLC
  • Loma Linda University Medical Center
  • Urology Group of Southern California
  • San Diego Clinical Trials
  • Providence Saint John's Health Center
  • Skyline Urology
  • University of Chicago Hospital
  • Comprehensive Urologic Care
  • First Urology, PSC
  • Wichita Urology Group
  • Regional Urology, LLC
  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates
  • Adult & Pediatric Urology, PC
  • Urology Center
  • New Jersey Urology
  • New Jersey Urology
  • Garden State Urology
  • Albany Medical Center
  • Great Lakes Physician dba WNY Urology Associates
  • AccuMed Research Associates
  • Manhattan Medical Research
  • Stony Brook Cancer Center
  • Associated Medical Professionals of NY, PLLC
  • UNC Chapel Hill Memorial Hospital
  • Clinical Research Solutions
  • Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
  • Penn State Health Milton S. Hershey Medical Center and College of Medicine
  • Fox Chase Cancer Center
  • University of Pittsburgh
  • Carolina Urologic Research Center
  • University of Texas Southwestern Medical Center
  • Urology San Antonio
  • Multiprofile Hospital for Active Treatment "Puls", Department of Urology
  • Multiprofile Hospital for Active Treatment - Blagoevgrad
  • Complex Oncology Center - Burgas
  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
  • Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
  • Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
  • University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
  • Multiprofile Hospital for Active Treatment Park Hospital
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology
  • University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology
  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
  • Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
  • University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
  • Multiprofile Hospital for Active Treatment - Targovishte
  • Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
  • Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
  • University Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
  • First Private Hospital Vratsa, Department of Urology
  • Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
  • East Viru Central Hospital, Surgery Clinic
  • East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
  • West Tallinn Central Hospital Ltd., Department of Urology
  • North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
  • Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
  • LTD Central University Clinic After Academic N. Kipshidze
  • JSC Jerarsi, Department of Urology
  • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
  • LTD Gidmedi, Urology Department
  • LTD L. Managadze National Center of Urology, Department of Urology
  • LTD MMT Hospital, Urology Department
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology
  • Pineo Medical Ecosystem Ltd., Department of Urology
  • Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
  • Rambam Health Care Campus
  • Lady Davis Carmel Medical Center
  • Edith Wolfson Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Liepajas Regional Hospital, Urology Department
  • P. Stradins Clinical University Hospital, Center for Urology
  • LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
  • Daugavpils Regional Hospital, Urology Department
  • Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology
  • AKMED
  • Prof.E Michalowski Specialist Hospital
  • SCM sp. z o.o. (LLC)
  • "City Clinic" Limited Liability Company
  • Miedzyleski Specialist Hospital in Warsaw, Department of Urology
  • Sverdlovsk Regional Clinical Hospital #1
  • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
  • D.D. Pletnyov City Clinical Hospital, Department of Oncourology
  • Moscow City Oncology Hospital #62
  • Murmansk Bayandin Regional Clinical Hospital
  • Privolzhsky Regional Medical Center, Urology Department
  • Tsyb Medical Radiology Research Center, Oncourology Department
  • Clinical Oncology Center, Department of Urology and Oncology
  • N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology
  • Pyatigorsk City Clinical Hospital, Department of Urology
  • Leningrad Regional Clinical Oncology Center, Department of Chemotherapy
  • Aleksandrovskaya City Hospital, Department of Urology
  • St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology
  • A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology
  • St. Luka Clinical Hospital, Department of Urology
  • St.-Petersburg Scientific Research Institute of Phthisiopulmonology
  • Medical and Sanitary Unit #70 of "Passazhiravtotrans"
  • I.I. Mechnikov North-Western State Medical University, Department of Urology
  • Railway Clinical Hospital under OAO Russian Railways
  • First I.P. Pavlov State Medical University of St. Petersburg
  • N.N. Petrov National Medical Research Center of Oncology, Oncourology Department
  • City Hospital #15, Urology Department #12
  • Siberian State Medical University
  • Regional Oncology Center, Tyumen, Oncology Department
  • Republican Clinical Oncology Center
  • Volgograd Regional Center for Urology and Nephrology, Urology Department
  • Medical Center for Diagnostics and Prevention Plus
  • Clinical Center of Serbia, Clinic of Urology
  • Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
  • Clinical Hospital Center Zemun, Urology unit
  • Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
  • Chernihiv Medical Center of Modern Oncology
  • Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital
  • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department
  • Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2
  • Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology
  • Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care
  • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology
  • Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council
  • Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5
  • Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology
  • Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery
  • Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"
  • State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine
  • Volyn Regional Medical Oncology Centre
  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology
  • Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center
  • Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology
  • Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
  • Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology
  • Sumy Regional Clinical Oncology Center
  • Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy
  • Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council
  • Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"
  • Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UGN-102 ± TURBT

TURBT Alone

Arm Description

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).

TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month Visit (3 months after the initial TURBT).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Complete response rate (CRR)
CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.
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.
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.
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.
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.
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.

Full Information

First Posted
July 21, 2020
Last Updated
August 1, 2023
Sponsor
UroGen Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04688931
Brief Title
A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer
Acronym
ATLAS
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Alternate approach pursued
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
March 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UroGen Pharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Keywords
Non-muscle invasive bladder cancer, Low grade non-muscle invasive bladder cancer, Intermediate risk non-muscle invasive bladder cancer, NMIBC, UGN-102, Mitomycin, Transurethral resection of bladder tumors, TURBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UGN-102 ± TURBT
Arm Type
Experimental
Arm Description
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).
Arm Title
TURBT Alone
Arm Type
Active Comparator
Arm Description
TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month Visit (3 months after the initial TURBT).
Intervention Type
Drug
Intervention Name(s)
UGN-102
Other Intervention Name(s)
UGN-102 (mitomycin) for intravesical solution
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
TURBT
Other Intervention Name(s)
Transurethral resection of bladder tumors
Intervention Description
The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
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.
Time Frame
Up to 21 months
Secondary Outcome Measure Information:
Title
Time to recurrence (TTR)
Description
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.
Time Frame
Up to 21 months
Title
Complete response rate (CRR)
Description
CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.
Time Frame
3 months
Title
Duration of response (DOR)
Description
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.
Time Frame
Up to 18 months
Title
Observed CRR at scheduled disease assessment time points
Description
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.
Time Frame
Up to 21 months
Title
Incidence of TURBT
Description
Incidence of TURBT is defined as the percentage of patients requiring TURBT and the average number of TURBTs per patient in each treatment arm.
Time Frame
3 months
Title
Changes from baseline in health-related quality of life
Description
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.
Time Frame
Up to 21 months
Title
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology, serum chemistry, and urinalysis).
Description
The percentage of patients with each type of event will be summarized.
Time Frame
Up to 21 months

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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