A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle … (NCT06331299) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
United States99 participantsStarted 2024-08-29
Plain-language summary
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
✓. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
✓. History of at least 1 prior episode of NMIBC. Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
✓. Has intermediate-risk disease, defined as having 1 or 2 of the following:
✓. Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
✓. Has adequate organ and bone marrow function as determined by routine laboratory tests:
✓. Has an anticipated life expectancy of at least the duration of the trial.
✓. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 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.
✕. Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed.
✕. Clinically significant urethral stricture that would preclude passage of a urethral catheter.
✕. History of:
✕. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC.