A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Stopped early · Phase 3
Conditions studied: Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
In brief
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).
Key facts
- Study ID
- NCT04688931
- Run by
- UroGen Pharma Ltd.
- People needed
- 282
- Starts
- 2021-02-19
- Expected to finish
- 2023-03-17
- Last updated by the study team
- 2024-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 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.
You may not qualify if…
- 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 stage 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.
Where it is running
- Loma Linda University Medical Center — Loma Linda, California, United States
- Urology Group of Southern California — Los Angeles, California, 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
- University of Chicago Hospital — Chicago, Illinois, United States
- Comprehensive Urologic Care — Lake Barrington, Illinois, United States
- First Urology, PSC — Jeffersonville, Indiana, United States
- Wichita Urology Group — Wichita, Kansas, United States
- Regional Urology, LLC — Shreveport, Louisiana, United States
- Chesapeake Urology Research Associates — Baltimore, Maryland, United States
- Chesapeake Urology Research Associates — Hanover, Maryland, United States
- Adult & Pediatric Urology, PC — Omaha, Nebraska, United States
- Urology Center — Las Vegas, Nevada, United States
- New Jersey Urology — Bloomfield, New Jersey, United States
- New Jersey Urology — Englewood, New Jersey, United States
- Garden State Urology — Morristown, New Jersey, United States
- Albany Medical Center — Albany, New York, United States
- Great Lakes Physician dba WNY Urology Associates — Cheektowaga, New York, United States
- AccuMed Research Associates — Garden City, New York, United States
- Manhattan Medical Research — New York, New York, United States
- Stony Brook Cancer Center — Stony Brook, New York, United States
- Associated Medical Professionals of NY, PLLC — Syracuse, New York, United States
- UNC Chapel Hill Memorial Hospital — Chapel Hill, North Carolina, United States
- Arizona Institute of Urology, PLLC — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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