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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Named Patient Program for Mitomycin for Pyelocalyceal Solution
- ClinicalTrials.gov ID
- NCT05494411
- Acronym / sponsor ID
- UT003
- 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
- Keywords
- Low-grade Upper Tract Urothelial Cancer, LG-UTUC, UGN-101, Mitomycin
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- UroGen Pharma Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tanner Pharma Group
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin for pyelocalyceal solutionAlso: JELMYTO | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
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..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Louie, MD, MPH, MSC (+1-855-987-6436, michael.louie@urogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.