Urothelial Cancer of Renal PelvisNCT05494411
Named Patient Program for Mitomycin for Pyelocalyceal Solution
A study testing Mitomycin for pyelocalyceal solution in people with Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma of the Renal Pelvis and Ureter, run by UroGen Pharma Ltd..
Trial summary
This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Ureter
- What is being tested?
- Mitomycin for pyelocalyceal solution
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.
- Conditions
- Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent, Urothelial Carcinoma, Urothelial Carcinoma Recurrent
- Being tested
- Mitomycin for pyelocalyceal solution
- Keywords
- Low-grade Upper Tract Urothelial Cancer, LG-UTUC, UGN-101, Mitomycin
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin for pyelocalyceal solutionDrug
Also called JELMYTO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Cancer of Renal PelvisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- UroGen Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tanner Pharma Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494411
- Sponsor's protocol ID
- UT003
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2022
- Last updated
- 15 Sep 2026
- Results posted
- No