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Named Patient Program for Mitomycin for Pyelocalyceal Solution

Primary Purpose

Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Ureter

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

Mitomycin for pyelocalyceal solution

About this trial

This is an expanded access trial for Urothelial Cancer of Renal Pelvis focused on measuring Low-grade Upper Tract Urothelial Cancer, LG-UTUC, UGN-101, Mitomycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT05494411

First Posted

August 5, 2022

Last Updated

August 5, 2022

Sponsor

UroGen Pharma Ltd.

Collaborators

Tanner Pharma Group

1. Study Identification

Unique Protocol Identification Number

NCT05494411

Brief Title

Named Patient Program for Mitomycin for Pyelocalyceal Solution

Study Type

Expanded Access

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UroGen Pharma Ltd.

Collaborators

Tanner Pharma Group

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Mitomycin for pyelocalyceal solution

Other Intervention Name(s)

JELMYTO

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristen Scholz

Phone

+1 843-628-9222

kristen.scholz@urogen.com

12. IPD Sharing Statement

Learn more about this trial

Named Patient Program for Mitomycin for Pyelocalyceal Solution

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