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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

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