Efficacy and Safety of UGN-101 in Recurrent Patients

• Status: Withdrawn
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UroGen Pharma Ltd.
• Treatments: Mitomycin; Mitomycins

Criteria

Main Inclusion Criteria:

1. Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial TC-UT-03).

2. 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.

3. Urine wash cytology sampled from the UUT documenting the absence of HG urothelial cancer.

4. Patients must have adequate organ and bone marrow function as determined by routine laboratory tests.

5. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis

Main Exclusion Criteria:

1. Patient intends to be treated with systemic chemotherapy during the duration of the trial.

2. Patient with urinary obstruction.

3. Inability to deliver the IP to the UUT.

4. 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.

5. Patient has a contraindication to mitomycin treatment, or known sensitivity to mitomycin.