The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
NCT ID: NCT02793128
Last Updated: 2020-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2017-04-04
2020-03-05
Brief Summary
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Detailed Description
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Upon signing of informed consent, the patients will undergo a screening visit for eligibility evaluation. Eligible patients will be treated with UGN-101 once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate complete response (CR) will be treated with UGN-101 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 Primary Disease Evaluation (PDE) Visit, during which safety and efficacy will be assessed, will take place. During this visit, the ablative effect of the UGN-101 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 UGN-101 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 Principal Investigator (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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UGN-101 instillations
The Mitomycin C (MMC) concentration of UGN-101 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.
UGN-101 instillations
Treatment with UGN-101 once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate complete response (CR) will be treated with UGN-101 once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
Interventions
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UGN-101 instillations
Treatment with UGN-101 once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate complete response (CR) will be treated with UGN-101 once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Naive or recurrent patients with low grade (LG), non-invasive Upper Tract Urothelial Carcinoma (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 High Grade (HG) urothelial cancer, diagnosed not more than 2 months prior to the screening.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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UroGen Pharma Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Seth Lerner, M.D.
Role: STUDY_CHAIR
Baylor College of Medicine
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Loma Linda Cancer Center
Loma Linda, California, United States
University of California
Los Angeles, California, United States
Providence Medical Institute
Santa Monica, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Loyola University Medical Center, Department of Urology
Maywood, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
John Hopkins University
Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic health system
Rochester, Minnesota, United States
Urology Center Las Vegas
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Montefiore Medical Center (Albert Einstein)
The Bronx, New York, United States
University of north carolina - chapel hill
Chapel Hill, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Penn State College of Medicine
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
MD Anderson
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Seattle Cancer Care Alliance (University of Washington)
Seattle, Washington, United States
Hasharon Hospital (Rabin Medical Center)
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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References
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Pierorazio PM, Kleinmann N, Shabsigh A, Hu B, Raman JD, Kaimakliotis H, Sankin A, Singla N, Meads A, Burger B, Raju S, Louie MJ, Chamie K, Weizer A, Schoenberg M. Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma With UGN-101, a Mitomycin Reverse Thermal Gel. J Urol. 2025 Mar;213(3):313-322. doi: 10.1097/JU.0000000000004331. Epub 2024 Nov 19.
Shabsigh A, Kleinmann N, Smith AB, Scherr D, Seltzer E, Schoenberg M, Lerner SP. Pharmacokinetics of UGN-101, a mitomycin-containing reverse thermal gel instilled via retrograde catheter for the treatment of low-grade upper tract urothelial carcinoma. Cancer Chemother Pharmacol. 2021 Jun;87(6):799-805. doi: 10.1007/s00280-021-04246-w. Epub 2021 Mar 7.
Kokorovic A, Matin SF. UGN-101 (mitomycin gel): a novel treatment for low-grade upper tract urothelial carcinoma. Ther Adv Med Oncol. 2020 Jul 3;12:1758835920937950. doi: 10.1177/1758835920937950. eCollection 2020.
Kleinmann N, Matin SF, Pierorazio PM, Gore JL, Shabsigh A, Hu B, Chamie K, Godoy G, Hubosky S, Rivera M, O'Donnell M, Quek M, Raman JD, Knoedler JJ, Scherr D, Stern J, Weight C, Weizer A, Woods M, Kaimakliotis H, Smith AB, Linehan J, Coleman J, Humphreys MR, Pak R, Lifshitz D, Verni M, Adibi M, Amin MB, Seltzer E, Klein I, Konorty M, Strauss-Ayali D, Hakim G, Schoenberg M, Lerner SP. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol. 2020 Jun;21(6):776-785. doi: 10.1016/S1470-2045(20)30147-9. Epub 2020 Apr 29.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TC-UT-03-P
Identifier Type: -
Identifier Source: org_study_id