Named Patient Program for Mitomycin for Pyelocalyceal Solution

Sponsor

UroGen Pharma Ltd. (Industry)

Overall Status

Available

CT.gov ID

NCT05494411

Collaborator

Tanner Pharma Group (Other)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Mitomycin for pyelocalyceal solution

Study Design

Study Type:

Expanded Access

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.