At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 71 enrolled
Drug / intervention
UGN-101 instillationsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of UGN-101 on Ablation of Upper Urinary Tract Urothelial Carcinoma
In Brief
A Phase 3 clinical trial evaluating UGN-101 instillations for Carcinoma, Transitional Cell and Transitional Cell Carcinoma of Renal Pelvis. Completed, enrolled 71 participants across 24 sites in 2 countries.
Detailed Summary
The study is investigating the ability of UroGen's UGN-101 to treat urothelial carcinoma tumors from the upper urinary tract.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartApr 2017
Primary CompletionApr 2019
Study CompletionMar 2020
TodayJul 2026
First PostedJun 8, 2016
Enrollment StartApr 4, 2017
Primary CompletionApr 5, 2019
Study CompletionMar 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.1 years ago
Interventions
UGN-101 instillationsdrug
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.