Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

  • STATUS
    Recruiting
  • End date
    Mar 15, 2022
  • participants needed
    80
  • sponsor
    Mayo Clinic
Updated on 28 June 2021
EGFR
burning
egfr inhibitor
skin biopsy

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.

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.

Details
Condition Rash, Skin Burning Sensation, dysesthesia, rashes, eruption, spots, skin rashes, skin rash
Treatment laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, Placebo, Ketoconazole
Clinical Study IdentifierNCT03471364
SponsorMayo Clinic
Last Modified on28 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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