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


Condition: Carcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal Pelvis

Intervention:

  • Drug: MitoGel™ instillations

Purpose: 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).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02793128

Sponsor: UroGen Pharma Ltd.

Primary Outcome Measures:

  • Measure: Complete Response (CR) Rate defined as percent of patients with CR at the Primary Disease Evaluation (PDE) Visit
  • Time Frame: An average of 11 weeks
  • Safety Issue:
  • Measure: Adverse events rate
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Long Term Durability of Complete Response (CR)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: CR rate at 3, 6 and 9 month after the PDE.
  • Time Frame: 3, 6 and 9 month
  • Safety Issue:
  • Measure: Partial response (PR) to treatment
  • Time Frame: An average of 11 weeks
  • Safety Issue:
  • Measure: MMC level in the plasma for sub-group of patients (n=6)
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: MMC level in the plasma for sub-group of patients (n=6)
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 74

Study Start Date: April 4, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
  4. Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ) showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the screening.
  5. Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm.
  6. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of HG urothelial cancer, diagnosed not more than 2 months prior to the screening.
  7. 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
  2. The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
  3. Carcinoma in situ (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.

Contact:

  • Ifat Klein, Phd
  • +972-9-770-7629

Locations:

  • Alaska Urological Institute
  • Anchorage Alaska 99503 United States
  • Mayo Clinic Hospital
  • Phoenix Arizona 85054 United States
  • University of California
  • Davis California 95616 United States
  • Loma Linda Cancer Center
  • Loma Linda California 92354 United States
  • USC Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • University of California
  • Los Angeles California 90095 United States
  • Providence Medical Institute
  • Santa Monica California 90404 United States
  • Urology Center of Colorado
  • Denver Colorado 80211 United States
  • University of Miami
  • Coral Gables Florida 33146 United States
  • Mayo Clinic Florida
  • Jacksonville Florida 32224 United States
  • Loyola University Medical Center, Department of Urology
  • Maywood Illinois 60153 United States
  • Indiana University School of Medicine
  • Indianapolis Indiana 46202 United States
  • University of Iowa
  • Iowa City Iowa 52242 United States
  • John Hopkins University
  • Baltimore Maryland 21218 United States
  • University of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States
  • Michigan Institute of Urology
  • West Bloomfield Michigan 48322 United States
  • University of Minnesota
  • Minneapolis Minnesota 55455 United States
  • Mayo Clinic health system
  • Rochester Minnesota 55905 United States
  • Urology Center Las Vegas
  • Las Vegas Nevada 89144 United States
  • Montefiore Medical Center (Albert Einstein)
  • Bronx New York 10467 United States
  • Western New York Urology Associates
  • Cheektowaga New York 14225 United States
  • Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
  • New York New York 10032-3784 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Weill Cornell Medical Center
  • New York New York 10065 United States
  • University of north carolina - chapel hill
  • Chapel Hill North Carolina 27514 United States
  • Duke University
  • Durham North Carolina 27708 United States
  • Cleveland Clinic
  • Cleveland Ohio 44195 United States
  • The Ohio State University Wexner Medical Center
  • Columbus Ohio 43210 United States
  • Penn State College of Medicine
  • Hershey Pennsylvania 17033 United States
  • Thomas Jefferson University Hospitals
  • Philadelphia Pennsylvania 19107 United States
  • University of Pittsburgh Medical Center
  • Pittsburgh Pennsylvania 15213 United States
  • Carolina Urologic Research Center (CURC)
  • Myrtle Beach South Carolina 29572 United States
  • MD Anderson
  • Houston Texas 77006 United States
  • Baylor College of Medicine
  • Houston Texas 77030 United States
  • Urology of Virginia
  • Norfolk Virginia 23507 United States
  • Seattle Cancer Care Alliance (University of Washington)
  • Seattle Washington 98109--1023 United States
  • Nova Scotia Health Authority
  • Halifax Nova Scotia Canada
  • London Health Sciences Centre
  • London Ontario N6A 5W9 Canada
  • Rambam Health Care Campus
  • Haifa 3109601 Israel
  • Hasharon Hospital (Rabin Medical Center)
  • Petah Tikva 49372 Israel
  • Sheba Medical Center
  • Ramat Gan 52621 Israel

View trial on ClinicalTrials.gov


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