Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
NCT ID: NCT03471364
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
58 participants
INTERVENTIONAL
2018-09-25
2024-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28.
Ketoconazole
Applied topically
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (placebo)
Participants apply placebo topically BID on days 1-28.
Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Applied topically
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Ketoconazole
Applied topically
Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Applied topically
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 an allergy or intolerance to sulfites
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Aminah Jatoi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Carle on Vermilion
Danville, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
University of Rochester
Rochester, New York, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2018-00355
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC17C1
Identifier Type: OTHER
Identifier Source: secondary_id
17-007786
Identifier Type: OTHER
Identifier Source: secondary_id
MC17C1
Identifier Type: -
Identifier Source: org_study_id
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