Status:
COMPLETED
Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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
- Patient has a prior allergy or intolerance of ketoconazole
- Patient has an allergy or intolerance to sulfites
Key Trial Info
Start Date :
September 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03471364
Start Date
September 25 2018
End Date
September 15 2024
Last Update
October 8 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Carle on Vermilion
Danville, Illinois, United States, 61832
2
Carle Cancer Center
Urbana, Illinois, United States, 61801
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
4
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426