The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
The study is investigating the ability of UroGen's UGN-101 to treat urothelial carcinoma tumors from the upper urinary tract.
Inclusion Criteria
- Patient is at least 18 years of age.
- Naive or recurrent patients with low grade (LG), non-invasive Upper Tract Urothelial Carcinoma (UTUC) in the pyelocalyceal system.
- Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
- 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.
- Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm.
- 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.
- 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
- Patient received Bacille de Calmette et Guérin (BCG) treatment for Urothelial carcinoma (UC) during the 6 months prior to Visit 1.
- The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
- Carcinoma in situ (CIS) in the past in the urinary tract.
- Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
- Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
- Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02793128.
Locations matching your search criteria
United States
North Carolina
Durham
Ohio
Cleveland
Trial TC-UT-03 is a prospective, open label, single-arm trial, designed to assess the
efficacy, safety, and tolerability of treatment with UGN-101 instilled in the upper
urinary system of patients with non-invasive low-grade (LG), Upper Tract Urothelial
Carcinoma (UTUC).
Upon signing of informed consent, the patients will undergo a screening visit for
eligibility evaluation. Eligible patients will be treated 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.
Five (5) weeks (± 1 w) following the last instillation, the Primary Disease Evaluation
(PDE) Visit, during which safety and efficacy will be assessed, will take place. During
this visit, the ablative effect of the UGN-101 will be assessed visually, by upper tract
washed urine cytology, and if there are remaining tumors, by biopsy or brush biopsy if
technically feasible.
Patient demonstrating CR at PDE will undergo monthly maintenance instillations of UGN-101
up to 11 months post PDE. Safety follow-up for these patients will be done until one
month post last instillation or at the end of the follow-up period in FU visit 12, which
is the earlier.
For patients who did not demonstrate Complete Response, to the extent that it is
possible, all remaining tumors lesions will be biopsied. The patients shall undergo any
additional surgical or other treatment the Principal Investigator (PI) decides deem
necessary to remove remaining tumor.
An independent Data Monitoring Committee (DMC) was assigned to this trial. Accumulating
safety, tolerability and efficacy data will be monitored periodically by the DMC
according to a pre-specified process and frequency detailed in the DMC charter.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationUroGen Pharma
- Primary IDTC-UT-03-P
- Secondary IDsNCI-2017-00020
- ClinicalTrials.gov IDNCT02793128