NCT05494411

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

First QC Date

August 5, 2022

Last Update Submit

February 25, 2025

Conditions

Keywords

Low-grade Upper Tract Urothelial CancerLG-UTUCUGN-101Mitomycin

Interventions

Also known as: JELMYTO

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Michael Louie, MD, MPH, MSC

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 10, 2022

Last Updated

February 28, 2025

Record last verified: 2025-02