WithdrawnPhase 3

Efficacy and Safety of UGN-101 in Recurrent Patients

Stopped: Due to projected low enrollment, it has decided not to move forward with the study.

United States, Israel0Started 2019-10-01

Plain-language summary

This trial is designed to evaluate the efficacy and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial TC-UT-03).
✓. Biopsy taken from 1 or more tumors located in the UUT shows LG urothelial carcinoma (up to 2 months before Visit 0). If there are tumors in both the kidney and the ureter, at least 1 biopsy should be taken from each location.
✓. Urine wash cytology sampled from the UUT documenting the absence of HG urothelial cancer.
✓. Patients must have adequate organ and bone marrow function as determined by routine laboratory tests.
✓. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis

Exclusion criteria

✕. Patient intends to be treated with systemic chemotherapy during the duration of the trial.
✕. Patient with urinary obstruction.
✕. Inability to deliver the IP to the UUT.
✕. Patient has any other medical or mental condition(s) that make(s) their participation in the trial unadvisable in the opinion of the treating investigator.
✕. Patient has a contraindication to mitomycin treatment, or known sensitivity to mitomycin.

What they're measuring

Complete response (CR) rate

Timeframe: An average of 11 weeks

Trial details

NCT IDNCT04006691

SponsorUroGen Pharma Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-31

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