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BRIEF TITLE: Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma


  • Org Study ID: TC-UT-03-P
  • Secondary ID:
  • NCT ID: NCT02793128
  • NCT Alias:
  • Sponsor: UroGen Pharma Ltd. - Industry
  • Source: UroGen Pharma Ltd.

Description

To see how MitoGel works, please watch the video below:



Brief Summary

The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).

Detailed Description


Trial TC-UT-03 is a prospective, single-arm trial, designed to assess the efficacy, safety,
and tolerability of treatment with MitoGel™ instilled in the upper urinary system of patients
with non-invasive low-grade (LG), UTUC.

Upon signing of informed consent, the patients will undergo a screening visit for eligibility
evaluation. Eligible patients will be treated with MitoGel™ once weekly for a total of 6
times; in a retrograde fashion. Patients who will demonstrate CR will be treated with
MitoGel™ once monthly as a maintenance therapy for a total of 11 instillations or up to the
first recurrence whichever comes first.

Five (5) weeks (± 1 w) following the last instillation, the PDE Visit, during which safety
and efficacy will be assessed, will take place. During this visit, the ablative effect of the
MitoGel™ will be assessed visually, by upper tract washed urine cytology, and if there are
remaining tumors, by biopsy or brush biopsy if technically feasible.

Patient demonstrating CR at PDE will undergo monthly maintenance instillations of MitoGel™ up
to 11 months post PDE. Safety follow-up for these patients will be done until one month post
last instillation or at the end of the follow-up period in FU visit 12, which is the earlier.

For patients who did not demonstrate Complete Response, to the extent that it is possible,
all remaining tumors lesions will be biopsied. The patients shall undergo any additional
surgical or other treatment the PI decides deem necessary to remove remaining tumor.

An independent Data Monitoring Committee (DMC) was assigned to this trial. Accumulating
safety, tolerability and efficacy data will be monitored periodically by the DMC according to
a pre-specified process and frequency detailed in the DMC charter.

Overal Status Start Date Phase Study Type
Recruiting April 4, 2017 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Complete Response (CR) Rate defined as percent of patients with CR at the Primary Disease Evaluation (PDE) Visit

Primary Outcome 1 - Time Frame: an average of 11 weeks

Primary Outcome 2 - Measure: Adverse events rate

Primary Outcome 2 - Time Frame: 2 years

Condition:

  • Carcinoma, Transitional Cell

Eligibility

Criteria:
Main Inclusion Criteria:

1. Patient is at least 18 years of age.

2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.

3. Patient has at least one (1) measurable and biopsy-confirmed papillary LG tumor,
evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.

4. Following biopsy patient should have at least one remaining lesion with a diameter of
5 mm.

5. Patient with bilateral LG UTUC may be enrolled if at least one side meets the
inclusion criteria for the trial and if the other kidney does not require further
treatments (The other kidney can be treated prior to the beginning of the study).

Main Exclusion Criteria:

1. Patient received BCG treatment for UC during the 6 months prior to Visit 1.

2. The patient has untreated concurrent urothelial cancer in other locations other than
the target area (unless treated during screening)

3. CIS in the past in the urinary tract.

4. Patient has a history of invasive urothelial carcinoma in the urinary tract during the
past 5 (Five) years.

5. Patient has a history of high grade papillary urothelial carcinoma in the urinary
tract during the past 2 (Two) years.

6. Patient is actively being treated or intends to be treated with systemic chemotherapy
during the duration of the trial.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ifat Klein, Phd

Role: Study Director

Affiliation: UroGen-Parma LTD

Overall Contact

Name: Ifat Klein, Phd

Phone: +972-9-770-7629

Email: ifatk@urogen.com

Locations

Facility Status Contact
Alaska Urological Institute
Anchorage, Alaska 99503
United States
Recruiting Josh Logan, MD
907-276-1455
Joshuaelogan@gmail.com
University of California
Davis, California 95616
United States
Recruiting Marc Dall'Era, MD
916-734-2893
mdallera@ucdavis.edu
University of California
Los Angeles, California 90095
United States
Recruiting Karim Chamie, MD
310-206-8183
kchamie@mednet.ucla.edu
Providence Medical Institute
Santa Monica, California 90404
United States
Recruiting Jennifer Linehan, M.D.

Jennifer.Linehan@providence.org
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Recruiting Raymond Pak, M.D.
404-683-5298
Pak.Raymond@mayo.edu
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
Recruiting Hristos Kaimakliotis, M.D.

hkaimakl@iupui.edu
University of Iowa
Iowa City, Iowa 52242
United States
Recruiting Mike O'Donnell, M.D.

michael-odonnell@uiowa.edu
John Hopkins University
Baltimore, Maryland 21218
United States
Recruiting Phillip Pierorazio, MD
410-955-6850
philpierorazio@jhmi.edu
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United States
Recruiting Alon Weizer, M.D.

aweizer@umich.edu
University of Minnesota
Minneapolis, Minnesota 55455
United States
Recruiting Christopher Weight, M.D.
734-232-0061
cjweight@umn.edu
Mayo Clinic health system
Rochester, Minnesota 55905
United States
Recruiting Lance Mynderse, M.D.
507-284-2297
Mynderse.lance@mayo.edu
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York, New York 10032-3784
United States
Recruiting Ojas Shah, M.D.

os2302@cumc.columbia.edu
Weill Cornell Medical Center
New York, New York 10065
United States
Recruiting Douglas S Scherr, MD
212-746-5788
dss2001@med.cornell.edu
Montefiore Medical Center (Albert Einstein)
The Bronx, New York 10467
United States
Recruiting Joshua Stern, MD
347-842-1715
jstern@montefiore.org
University of north carolina - chapel hill
Chapel Hill, North Carolina 27514
United States
Recruiting Michael Woods, MD
919-537-3505
Michael_woods@med.unc.edu
Cleveland Clinic
Cleveland, Ohio 44195
United States
Recruiting Andrew Stephenson, M.D.
216-444-0124
stephea2@cccf.org
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Recruiting Ahmad Shabsigh, MD
614-293-7833
ahmad.shabsigh@osumc.edu
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Recruiting Jefferey Gingrich, MD
412-605-3015
gingrichjr@upmc.edu
MD Anderson
Houston, Texas 77006
United States
Recruiting Surena Matin, MD
713-792-3250
surmatin@mdanderson.org
Baylor College of Medicine
Houston, Texas 77030
United States
Recruiting Guilherme Godoy, MD
713-798-7296
godoy@bcm.edu
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Recruiting Michael Williams, M.D.

MichaelWilliams@urologyofva.net
Sheba Medical Center
Ramat Gan, 52621
Israel
Recruiting Nir Kleinmann, M.D.
952-53-3398845
nir.kleinmann@gmail.com