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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 1.
  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.

Study Design

Phase
Phase 3
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MitoGel™ instillations
The MMC concentration of MitoGel™ to be used in this trial will be 4 mg MMC per 1 mL of TC-3 gel, maximum dose is 15ml. 6 once weekly intravesical instillations for the ablation treatment.
  • Drug: MitoGel™ instillations
    Treatment 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.
    Other names:
    • MitoGel

Recruiting Locations

Montefiore Medical Center (Albert Einstein)
Bronx, New York 10467
Contact:
Joshua Stern, MD
347-842-1715
jstern@montefiore.org

More Details

NCT ID
NCT02793128
Status
Recruiting
Sponsor
UroGen Pharma Ltd.

Study Contact

Ifat Klein, Phd
+972-9-770-7629
ifatk@urogen.com

Detailed Description

Trial TC-UT-03 is a prospective, open label, 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.