Last updated on December 2018

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

Brief description of 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).

Detailed Study 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.

Clinical Study Identifier: NCT02793128

Contact Investigators or Research Sites near you

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Josh Logan, MD

Alaska Urological Institute
Anchorage, AK United States

Mitchell Humphreys, M.D.

Mayo Clinic Hospital
Phoenix, AZ United States

Marc Dall'Era, MD

University of California
Davis, CA United States

Brian Hu, M.D.

Loma Linda Cancer Center
Loma Linda, CA United States

Karim Chamie, MD

University of California
Los Angeles, CA United States

Jennifer Linehan, M.D.

Providence Medical Institute
Santa Monica, CA United States

Raymond Pak, M.D.

Mayo Clinic Florida
Jacksonville, FL United States

Hristos Kaimakliotis, M.D.

Indiana University School of Medicine
Indianapolis, IN United States

Mike O'Donnell, M.D.

University of Iowa
Iowa City, IA United States

Phillip Pierorazio, MD

John Hopkins University
Baltimore, MD United States

Alon Weizer, M.D.

University of Michigan Comprehensive Cancer Center
Ann Arbor, MI United States

Christopher Weight, M.D.

University of Minnesota
Minneapolis, MN United States

Marcelino Rivera, M.D.

Mayo Clinic health system
Rochester, MN United States

Ojas Shah, M.D.

Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York, NY United States

Douglas S Scherr, MD

Weill Cornell Medical Center
New York, NY United States

Michael Woods, MD

University of north carolina - chapel hill
Chapel Hill, NC United States

Brant Inman, M.D.

Duke University
Durham, NC United States

Andrew Stephenson, M.D.

Cleveland Clinic
Cleveland, OH United States

Ahmad Shabsigh, MD

The Ohio State University Wexner Medical Center
Columbus, OH United States

Jay Raman, M.D.

Penn State College of Medicine
Hershey, PA United States

Scott Hubosky, M.D.

Thomas Jefferson University Hospitals
Philadelphia, PA United States

Jefferey Gingrich, MD

University of Pittsburgh Medical Center
Pittsburgh, PA United States

Surena Matin, MD

MD Anderson
Houston, TX United States

Guilherme Godoy, MD

Baylor College of Medicine
Houston, TX United States

Nir Kleinmann, M.D.

Sheba Medical Center
Ramat Gan, Israel

Marcus Quek, M.D.

Loyola University Medical Center, Department of Urology
Maywood, IL United States

Joshua Stern, MD

Montefiore Medical Center (Albert Einstein)
Bronx, NY United States

Michael Williams, M.D.

Urology of Virginia
Norfolk, VA United States

Gilad Amiel, M.D.

Rambam Health Care Campus
Haifa, Israel

John Gore, M.D.

Seattle Cancer Care Alliance (University of Washington)
Seattle, WA United States

Mark Gonzalgo, M.D.

University of Miami
Coral Gables, FL United States

Neal Shore, M.D.

Carolina Urologic Research Center (CURC)
Myrtle Beach, SC United States

John Joseph Bodkin, M.D.

Western New York Urology Associates
Cheektowaga, NY United States

Guido Delbagni, M.D.

Memorial Sloan Kettering Cancer Center
New York, NY United States

Kenneth Kernen, M.D.

Michigan Institute of Urology
West Bloomfield, MI United States

David Lifshitz, M.D.

Hasharon Hospital (Rabin Medical Center)
Petah Tikva, Israel

Siamak Daneshmand, M.D.

USC Norris Comprehensive Cancer Center
Los Angeles, CA United States

Joseph Chin, M.D.

London Health Sciences Centre
London, ON Canada

Ricardo Rendon, M.D.

Nova Scotia Health Authority
Halifax, NS Canada

Michael Verni, M.D.

Urology Center Las Vegas
Las Vegas, NV United States

Lawrence Karsh, M.D.

Urology Center of Colorado
Denver, CO United States

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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