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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-009940
    • Jacksonville, Florida: 16-009940
    • Rochester, Minnesota: 16-009940
    NCT ID: NCT02793128
    Sponsor Protocol Number: TC-UT-03-P

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Cher-Yee Lye CCRP

(480)342-6012

Lye.Cher-Yee@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Rachel White

(904)953-8513

White.Rachel2@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Tessa Kroeninger

(507)538-6107

Kroeninger.Tessa@mayo.edu

Additional contact information

Cancer-related trials contact form

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

International patient clinical studies questions