NCT04006691

Brief 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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_3

Geographic Reach
2 countries

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

June 12, 2019

Last Update Submit

May 5, 2020

Conditions

CarcinomaTransitional Cell CarcinomaTransitional Cell Cancer of the Renal Pelvis and Ureter

Keywords

TC-3MitoGelUGN-101UTUCUreteralUpper TractCarcinomaKidneyRenalUreterGelLocalMitomycin CProlonged ReleaseSlow ReleaseKidney SparingT1T0Low GradeTransitional Cell Carcinoma of Renal PelvisTCC

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR) rate

    Complete response defined dichotomously as "Success" if CR was confirmed at the end of the treatment period (PDE 2 Visit), and "Failure" otherwise.

    An average of 11 weeks

Secondary Outcomes (1)

  • Long-term durability of complete response (CR)

    3, 6, 9 and 12 months

Other Outcomes (5)

  • Incidence (number of patients) of adverse events

    15 months

  • Frequency (number of events) of adverse events

    15 months

  • Clinically meaningful changes in laboratory values of blood hematology, coagulation, liver and kidney function parameters and urinalysis

    15 months

  • +2 more other outcomes

Study Arms (1)

UGN-101 instillations

EXPERIMENTAL

The Mitomycin C (MMC) concentration of UGN-101 to be used in this trial will be 4 mg MMC per 1 mL of TC-3 gel, the maximum dose is 15ml. 3-6 once weekly intravesical instillations for the ablation treatment.

Drug: UGN-101 instillations

Interventions

UGN-101 instillationsDRUG

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

Also known as: UGN-101, MitoGelâ„¢
UGN-101 instillations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial TC-UT-03).
  • Biopsy taken from 1 or more tumors located in the UUT shows LG urothelial carcinoma (up to 2 months before Visit 0). If there are tumors in both the kidney and the ureter, at least 1 biopsy should be taken from each location.
  • Urine wash cytology sampled from the UUT documenting the absence of HG urothelial cancer.
  • Patients must have adequate organ and bone marrow function as determined by routine laboratory tests.
  • Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis

You may not qualify if:

  • Patient intends to be treated with systemic chemotherapy during the duration of the trial.
  • Patient with urinary obstruction.
  • Inability to deliver the IP to the UUT.
  • Patient has any other medical or mental condition(s) that make(s) their participation in the trial unadvisable in the opinion of the treating investigator.
  • Patient has a contraindication to mitomycin treatment, or known sensitivity to mitomycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA - University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

John Hopkins University

Baltimore, Maryland, 21218, United States

Location

Urology Center Las Vegas

Las Vegas, Nevada, 89144, United States

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

CarcinomaCarcinoma, Transitional Cell

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ifat Klein, Phd

    UroGen Pharma

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

July 5, 2019

Study Start

October 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)US(4)