The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Condition: Carcinoma, Transitional Cell; Transitional Cell Carcinoma of Renal Pelvis
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Intervention: UGN-101 instillations
Intervention description: Treatment with UGN-101 once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate complete response (CR) will be treated with UGN-101 once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TC-3; UTUC; Ureteral; Upper Tract; Carcinoma; Kidney; Renal; Gel; Local; Mitomycin C; Prolonged Release; Slow Release; Kidney Sparing; T1; T0; Low Grade; Transitional Cell Carcinoma of Renal Pelvis; TCC; UGN-101

Summary:

      The study is investigating the ability of UroGen's UGN-101 to treat urothelial carcinoma
      tumors from the upper urinary tract.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Patient is at least 18 years of age.

          2. Naive or recurrent patients with low grade (LG), non-invasive Upper Tract Urothelial
             Carcinoma (UTUC) in the pyelocalyceal system.

          3. Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15
             mm. The largest lesion should not exceed 15mm.

          4. Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ)
             showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the
             screening.

          5. Patient should have at least one remaining papillary LG tumor evaluated visually with
             a diameter of at least 5 mm.

          6. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of
             High Grade (HG) urothelial cancer, diagnosed not more than 2 months prior to the
             screening.

          7. Patient with bilateral LG UTUC may be enrolled if at least one side meets the
             inclusion criteria for the trial and if the other kidney does not require further
             treatments (The other kidney can be treated prior to the beginning of the study).

        Main Exclusion Criteria:

          1. Patient received Bacille de Calmette et Guérin (BCG) treatment for Urothelial
             carcinoma (UC) during the 6 months prior to Visit 1.

          2. The patient has untreated concurrent urothelial cancer in other locations other than
             the target area (unless treated during screening)

          3. Carcinoma in situ (CIS) in the past in the urinary tract.

          4. Patient has a history of invasive urothelial carcinoma in the urinary tract during the
             past 5 (Five) years.

          5. Patient has a history of high grade papillary urothelial carcinoma in the urinary
             tract during the past 2 (Two) years.

          6. Patient is actively being treated or intends to be treated with systemic chemotherapy
             during the duration of the trial.