Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Malignant Neoplasm

In brief

This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.

Key facts

Study ID

NCT03471364

Run by

Mayo Clinic

People needed

58

Starts

2018-09-25

Expected to finish

2024-09-15

Last updated by the study team

2025-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
• Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart =< 14 days of registration and continue for at least 28 days
• Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
• Patient must complete baseline quality of life (QOL) packet

You may not qualify if…

• Patient has a prior allergy or intolerance of ketoconazole
• Patient has an allergy or intolerance to sulfites

Where it is running

• Carle on Vermilion — Danville, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Park Nicollet Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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