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

Biopharmaceutical company UroGen Pharma Ltd is starting a new clinical trial of A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer.

This is a global 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).

The clinical trial starts in December 2020 and will continue throughout December 2023.

The inclusion conditions are:

  • 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.
  • 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.

and others.

The excluding conditions are:

  • 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.

and others.

The contacts and locations are the Manhattan Medical Research, New York, United States.

For more details: https://ichgcp.net/clinical-trials-registry/NCT04688931

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