A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (NCT04688931) | Clinical Trial Compass
TerminatedPhase 3
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Stopped: Alternate approach pursued
United States282 participantsStarted 2021-02-19
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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:
✓. 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:
✓. 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.