Spots Global Cancer Trial Database for Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

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Trial Identification

Brief Title: Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

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

Study ID: NCT03471364

Conditions

Malignant Neoplasm

Interventions

Ketoconazole

Laboratory Biomarker Analysis

Placebo Administration

Quality-of-Life Assessment

Questionnaire Administration

Study Description

Brief 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.