CompletedPhase 3

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

United States71 participantsStarted 2017-04-04

Plain-language summary

The study is investigating the ability of UroGen's UGN-101 to treat urothelial carcinoma tumors from the upper urinary tract.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit).

Timeframe: An average of 11 weeks

NCT IDNCT02793128

SponsorUroGen Pharma Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-05

Results submitted2020-09-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.