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Efficacy and Safety of UGN-101 in Recurrent Patients

NCT04006691 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-05-07

No results posted yet for this study

Summary

This trial is designed to evaluate the efficacy and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).

Conditions

  • Carcinoma
  • Transitional Cell Carcinoma
  • Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

DRUG

UGN-101 instillations

Treatment with UGN-101 once weekly for a total of 3-6 times; in a retrograde fashion.

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Ifat Klein, Phd · UroGen Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

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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 NCT04006691 on ClinicalTrials.gov