Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Malignant Neoplasm

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Drug: Ketoconazole; Other: Placebo Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03471364

R01CA207183 (U.S. NIH Grant/Contract)

NCI-2018-00355 (Registry Identifier)

17-007786 (Other Identifier)

MC17C1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Arm I (ketoconazole)

Experimental group

Description:

Participants apply ketoconazole topically BID on days 1-28.

Treatment:

Drug: Ketoconazole

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Arm II (placebo)

Placebo Comparator group

Description:

Participants apply placebo topically BID on days 1-28.

Treatment:

Other: Placebo Administration

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment