The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert McLaren, M.D.

Open for enrollment

Contact information:

Tessa Kroeninger CCRP

(507) 538-6107

Kroeninger.Tessa@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitchell Humphreys, M.D.

Open for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Raymond Pak, M.D., M.B.A.

Open for enrollment

Contact information:

Rachel Pung Page

White.Rachel2@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions