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Trial Title:
Named Patient Program for Mitomycin for Pyelocalyceal Solution
NCT ID:
NCT05494411
Condition:
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
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Recurrence
Mitomycins
Mitomycin
Conditions: Keywords:
Low-grade Upper Tract Urothelial Cancer
LG-UTUC
UGN-101
Mitomycin
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
Mitomycin for pyelocalyceal solution
Other name:
JELMYTO
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 in situations when
patients have exhausted all available treatment options.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Lead sponsor:
Agency:
UroGen Pharma Ltd.
Agency class:
Industry
Collaborator:
Agency:
Tanner Pharma Group
Agency class:
Other
Source:
UroGen Pharma Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494411