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NCT02793128 · ClinicalTrials.gov registry record · Phase 3
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
A Phase 3 study of Carcinoma, Transitional Cell and Transitional Cell Carcinoma of Renal Pelvis, sponsored by UroGen Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
- 20
- Study locations
NCT02793128: Completed Phase 3 study of Carcinoma, Transitional Cell and Transitional Cell Carcinoma of Renal Pelvis, sponsored by UroGen Pharma.
NCT02793128 is a Phase 3 study of Carcinoma, Transitional Cell and Transitional Cell Carcinoma of Renal Pelvis that has completed, run by UroGen Pharma. The registered enrollment target is 71 participants, below the 296-participant average among 5 other Carcinoma, Transitional Cell trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02793128, a Phase 3 study of Carcinoma, Transitional Cell and Transitional Cell Carcinoma of Renal Pelvis, has completed, sponsored by UroGen Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is investigating the ability of UroGen's UGN-101 to treat urothelial carcinoma tumors from the upper urinary tract.
Primary Outcome
The primary efficacy endpoint was the number of patients attaining complete response (CR) at the end of the treatment period (Primary Disease Evaluation (PDE) visit). The CR was defined dichotomously as "Success" if CR was confirmed at PDE visit (or relevant follow-up), and "Failure" otherwise.
Conditions Studied
Interventions
- DRUG UGN-101 instillations
Study Locations (20)
California
- Loma Linda Cancer Center - Loma Linda
- University of California - Los Angeles
- Providence Medical Institute - Santa Monica
New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical Center - New York
- Montefiore Medical Center (Albert Einstein) - The Bronx
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic health system - Rochester
Pennsylvania
- Penn State College of Medicine - Hershey
- Thomas Jefferson University Hospitals - Philadelphia
Arizona
- Mayo Clinic Hospital - Phoenix
Florida
- Mayo Clinic Florida - Jacksonville
Illinois
- Loyola University Medical Center, Department of Urology - Maywood
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-04-04 |
| Est. Completion | 2020-03-05 |
| Phase | Phase 3 |
What the finished NCT02793128 record still lists
NCT02793128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 296-participant average among 5 other Carcinoma, Transitional Cell trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Carcinoma, Transitional Cell appearing as the primary indexed condition, and to 1 intervention - of which UGN-101 instillations is the first listed.
NCT02793128 names 20 study sites across 14 states, led by California, New York, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02793128 about?
NCT02793128 is a clinical study titled "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.
What is the current status of trial NCT02793128?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2017-04-04. Estimated completion is 2020-03-05.
What conditions does trial NCT02793128 study?
This clinical trial studies the following conditions: Carcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal Pelvis.
What interventions are being tested in trial NCT02793128?
The interventions under investigation include: UGN-101 instillations (DRUG).
Who is sponsoring clinical trial NCT02793128?
This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02793128 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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