Bladder Cancer Clinical Trial
A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
Summary
This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
Full Description
Eligible patients will be randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 ± TURBT group will receive 6 once-weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone group will undergo TURBT.
Patients in both treatment groups will return to the clinic at approximately 3 months after the initiation of treatment (7 weeks ± 1 week after the last weekly instillation for the UGN-102 ± TURBT group and 12 weeks ± 1 week after TURBT for the TURBT alone group) to determine response to treatment. Patients determined to have a complete response (CR) will receive no further treatment and will enter the follow-up period of the study. Patients determined to have a non-complete response (NCR) will undergo TURBT of any remaining lesions and will 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 (approximately 24 months after the initiation of treatment) or until recurrence or death is documented, whichever occurs first. Patients determined to have a protocol-defined recurrence at any follow-up or unscheduled visit will be considered to have completed the study and released to the care of their treating physician.
The study is event-driven and patients may be followed beyond 24 months or additional patients may be enrolled to achieve the target number of events required for the study.
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.
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).
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 post 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.
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There are 126 Locations for this study
Tucson Arizona, 85704, United States
Loma Linda California, 92350, United States
Los Angeles California, 90017, United States
San Diego California, 92120, United States
Santa Monica California, 90404, United States
Sherman Oaks California, 91411, United States
Chicago Illinois, 60637, United States
Lake Barrington Illinois, 60010, United States
Jeffersonville Indiana, 47130, United States
Wichita Kansas, 67226, United States
Shreveport Louisiana, 71106, United States
Baltimore Maryland, 21204, United States
Hanover Maryland, 21076, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89144, United States
Bloomfield New Jersey, 07003, United States
Englewood New Jersey, 07631, United States
Morristown New Jersey, 07960, United States
Albany New York, 12208, United States
Cheektowaga New York, 14225, United States
Garden City New York, 11530, United States
New York New York, 10016, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Middleburg Heights Ohio, 44130, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15237, United States
Myrtle Beach South Carolina, 29572, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78229, United States
Blagoevgrad , 2700, Bulgaria
Blagoevgrad , 2700, Bulgaria
Burgas , 8000, Bulgaria
Gabrovo , 5300, Bulgaria
Lom , 3600, Bulgaria
Montana , 3400, Bulgaria
Pleven , 5800, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4000, Bulgaria
Plovdiv , 4002, Bulgaria
Plovdiv , 4003, Bulgaria
Ruse , 7000, Bulgaria
Shumen , 9700, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1606, Bulgaria
Targovishte , 7700, Bulgaria
Varna , 9000, Bulgaria
Varna , 9002, Bulgaria
Varna , 9010, Bulgaria
Veliko Tarnovo , 5000, Bulgaria
Vratsa , 3001, Bulgaria
Yambol , 8600, Bulgaria
Kohtla-Järve , 31025, Estonia
Tallinn , 10138, Estonia
Tallinn , 10617, Estonia
Tallinn , 13419, Estonia
Tartu , 50406, Estonia
Tbilisi , 0160, Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Haifa , 31096, Israel
Haifa , 34362, Israel
H̱olon , 58100, Israel
Petah tikva , 49100, Israel
Ramat Gan , 52620, Israel
Liepāja , LV-34, Latvia
Riga , LV-10, Latvia
Riga , LV-10, Latvia
Riga , LV-54, Latvia
Bydgoszcz , 85-16, Poland
Gliwice , 44-10, Poland
Katowice , 40-07, Poland
Kraków , 31-55, Poland
Warsaw , 02-47, Poland
Warsaw , 04-74, Poland
Ekaterinburg , 62010, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 10507, Russian Federation
Moscow , 12513, Russian Federation
Murmansk , 18304, Russian Federation
Nizhny Novgorod , 60300, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Penza , 44002, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 18866, Russian Federation
Saint Petersburg , 19331, Russian Federation
Saint Petersburg , 19401, Russian Federation
Saint Petersburg , 19404, Russian Federation
Saint Petersburg , 19404, Russian Federation
Saint Petersburg , 19406, Russian Federation
Saint Petersburg , 19500, Russian Federation
Saint Petersburg , 19506, Russian Federation
Saint Petersburg , 19527, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint Petersburg , 19820, Russian Federation
Tomsk , 63405, Russian Federation
Tyumen , 62504, Russian Federation
Ufa , 45005, Russian Federation
Volzhskiy , 40412, Russian Federation
Yaroslavl , 15004, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Belgrade , 11080, Serbia
Kragujevac , 34000, Serbia
Chernihiv , 14029, Ukraine
Chernivtsi , 58001, Ukraine
Chernivtsi , 58023, Ukraine
Dnipro , 49005, Ukraine
Dnipro , 49074, Ukraine
Dnipro , 49102, Ukraine
Ivano-Frankivs'k , 76008, Ukraine
Ivano-Frankivs'k , 76018, Ukraine
Kharkiv , 61037, Ukraine
Kharkiv , 61070, Ukraine
Kharkiv , 61166, Ukraine
Kherson , 73000, Ukraine
Kyiv , 04053, Ukraine
Luts'k , 43018, Ukraine
Lviv , 79010, Ukraine
Lviv , 79031, Ukraine
Lviv , 79059, Ukraine
Odesa , 65025, Ukraine
Odesa , 65074, Ukraine
Sumy , 40022, Ukraine
Ternopil' , 46023, Ukraine
Uzhhorod , 88014, Ukraine
Vinnytsia , 21029, Ukraine
Zaporizhia , 69600, Ukraine
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