Clinical trial NCT03471364: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-03-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who report an improvement in skin rash
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Incidence of skin toxicity
timeFrame: Up to 4 weeks
measure: Incidence of skin toxicity
timeFrame: Up to 4 weeks
measure: Incidence of adverse events for ketoconazole
timeFrame: Up to 4 weeks
Other outcomes:
measure: Change in PLA2G4D, PLOD2, and SALL4
timeFrame: Baseline up to 4 weeks
Locations:
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: