Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ketoconazole

Criteria

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• Patient has a prior allergy or intolerance of ketoconazole

• Patient has an allergy or intolerance to sulfites