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The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study

NCT02793128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-12-22

Study results available
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Summary

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

Conditions

  • Carcinoma, Transitional Cell
  • Transitional Cell Carcinoma of Renal Pelvis

Interventions

DRUG

UGN-101 instillations

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.

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Seth Lerner, M.D. · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2019-04-05
Completion
2020-03-05
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793128 on ClinicalTrials.gov