Phase 3
N=71
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Carcinoma, Transitional Cell · Transitional Cell Carcinoma of Renal Pelvis
Bottom Line
View on ClinicalTrials.gov: NCT02793128 ↗Enrolled (actual)
71
Serious AEs
39.4%
Results posted
Nov 2020
Primary outcome: Primary: The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit). — 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- UGN-101 instillations (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UroGen Pharma Ltd.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit). |
42 | — |
| SECONDARY The Key Secondary Efficacy Endpoint Was Long-term Durability of Complete Response (CR): Number of Patients Who Maintained CR at 12 Month Post PDE Visit. This Endpoint Was Defined Only for Those Patients Who Achieved CR at the PDE Visit. |
23 | — |
| SECONDARY Durability of Complete Response (CR) for Each Follow-up Time Point. |
35; 33; 28; 23 | — |
| SECONDARY Clinical Benefit for Patients With Partial Response (PR) at the Primary Disease Evaluation (PDE) Visit. Clinical Benefit Endpoint Was Analyzed Using the Intent-to-Treat (ITT) Analysis Set, Including Patients Who Achieved Partial Response at PDE Visit. |
8 | — |
| SECONDARY Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. |
1.27 | — |
| SECONDARY Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. |
1.27 | — |
| SECONDARY Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. |
1.27 | — |
Summary
The study is investigating the ability of UroGen's UGN-101 to treat urothelial carcinoma tumors from the upper urinary tract.
Eligibility Criteria
Main Inclusion Criteria:
- Patient is at least 18 years of age.
- Naive or recurrent patients with low grade (LG), non-invasive Upper Tract Urothelial Carcinoma (UTUC) in the pyelocalyceal system.
- Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
- 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.
- Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm.
- 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.
- 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:
- Patient received Bacille de Calmette et Guérin (BCG) treatment for Urothelial carcinoma (UC) during the 6 months prior to Visit 1.
- The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
- Carcinoma in situ (CIS) in the past in the urinary tract.
- Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
- Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
- Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Data sourced from ClinicalTrials.gov (NCT02793128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.