Named Patient Program for Mitomycin for Pyelocalyceal Solution

• 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

• Registration Number: NCT05494411
• Lead Sponsor: UroGen Pharma Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified