NCT03471364

Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

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: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Ketoconazole	Applied topically
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo Administration	Applied topically
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-09-25
• Primary completion: 2024-09-15
• Completion: 2024-09-15
• First posted: 2018-03-20
• Last updated: 2025-10-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study