Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash



Status:Recruiting
Conditions:Skin and Soft Tissue Infections, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:August 22, 2018
End Date:March 15, 2020

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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

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.

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.

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
We found this trial at
4
sites
Rochester, Minnesota 55905
Principal Investigator: Aminah Jatoi, M.D.
Phone: 855-776-0015
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Richard Dunne, M.D.
Phone: 585-273-2605
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Saint Louis Park, Minnesota 55426
Principal Investigator: Dylan Zylla, M.D.
Phone: 952-993-6723
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640 Jackson St
Saint Paul, Minnesota 55101
Principal Investigator: Dylan Zylla, M.D.
Phone: 952-993-6723
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Saint Paul, MN
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