Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Malignant Neoplasm Clinical Trial

Official title: Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients With an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To demonstrate that topical ketoconazole, an anti-androgen, palliates EGFR inhibitor-induced rash within a group of racially diverse cancer patients.

II. To explore the role of ribonucleic acid (RNA) sequencing to identify other targets that might be used at a later date for rash palliation.

III. To evaluate toxicities associated with topical ketoconazole.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants apply ketoconazole topically twice daily (BID) on days 1-28.

ARM II: Participants apply placebo topically BID on days 1-28.

After completion of study treatment, participants are followed up at 1 week. ;

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

• NCT number: NCT03471364
• Study type: Interventional
• Source: Mayo Clinic
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 22, 2018
• Completion date: March 15, 2025