Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

NCT03471364 | Completed Early Phase 1 DMC FDA Drug

• 4 other identifiers: MC17C1NCI-2018-00355R01CA20718317-007786
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who report an improvement in skin rash

  Assessed by Skindex-16. Will be estimated using the cumulative incidence function with time to improvement defined as the time from randomization to the first of the two consecutive weeks of improved symptom. The cumulative incidence of rash improvement after 4 weeks of treatment will be summarized separately by treatment arm. The difference in rash improvement incidences will be estimated and will be compared using two-sample Z-test.

  Up to 4 weeks

Secondary Outcomes (3)

• Incidence of skin toxicity

  Up to 4 weeks

• Incidence of skin toxicity

  Up to 4 weeks

• Incidence of adverse events for ketoconazole

  Up to 4 weeks

Other Outcomes (1)

• Change in PLA2G4D, PLOD2, and SALL4

  Baseline up to 4 weeks

Study Arms (2)

Arm I (ketoconazole)

EXPERIMENTAL

Participants apply ketoconazole topically BID on days 1-28.

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

Arm II (placebo)

PLACEBO COMPARATOR

Participants apply placebo topically BID on days 1-28.

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

Interventions

Ketoconazole DRUG

Applied topically

Also known as: Fungarest, Fungoral, Ketoderm, Ketoisdin, Nizoral, Orifungal M, Panfungol, R-41400, Xolegel

Arm I (ketoconazole)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (ketoconazole); Arm II (placebo)

Placebo Administration OTHER

Applied topically

Arm II (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (ketoconazole); Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (ketoconazole); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Carle on Vermilion

Danville, Illinois, 61832, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aminah Jatoi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 20, 2018
• Study Start: September 25, 2018
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (6)