← Back to Search

Anti-fungal Agent

Ketoconazole for Cancer-related Rash

Phase < 1
Waitlist Available
Led By Aminah Jatoi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial is testing ketoconazole to see if it can help treat people with a specific kind of rash caused by EGFR inhibitor therapy.

Who is the study for?
This trial is for people with a rash or skin burning from EGFR inhibitor cancer treatment, who will continue this treatment for at least 28 days. Participants must be willing to complete quality-of-life questionnaires and may need to provide a skin biopsy. It's not open to those allergic to ketoconazole or sulfites.Check my eligibility
What is being tested?
The study tests if ketoconazole can ease rashes caused by EGFR inhibitors in cancer patients. It involves comparing the effects of ketoconazole against a placebo while monitoring participants' quality of life through questionnaires and lab biomarker analysis.See study design
What are the potential side effects?
Ketoconazole might cause side effects such as nausea, headache, dizziness, stomach pain, or changes in liver function tests. The severity varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a rash or burning skin from EGFR inhibitor treatment.
Select...
I will start or continue an EGFR inhibitor treatment for at least 28 days soon.
Select...
I have filled out the baseline quality of life questionnaire.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who report an improvement in skin rash
Secondary outcome measures
Incidence of adverse events for ketoconazole
Incidence of skin toxicity
Other outcome measures
Change in PLA2G4D, PLOD2, and SALL4

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (ketoconazole)Experimental Treatment4 Interventions
Participants apply ketoconazole topically BID on days 1-28.
Group II: Arm II (placebo)Placebo Group4 Interventions
Participants apply placebo topically BID on days 1-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketoconazole
2011
Completed Phase 3
~1420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,289 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,177 Previous Clinical Trials
3,758,325 Total Patients Enrolled
Aminah JatoiPrincipal InvestigatorMayo Clinic
8 Previous Clinical Trials
236 Total Patients Enrolled

Media Library

Ketoconazole (Anti-fungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03471364 — Phase < 1
Cancer Research Study Groups: Arm I (ketoconazole), Arm II (placebo)
Cancer Clinical Trial 2023: Ketoconazole Highlights & Side Effects. Trial Name: NCT03471364 — Phase < 1
Ketoconazole (Anti-fungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03471364 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for enrolment in this research initiative?

"Based on the clinicaltrials.gov website, this research project is recruiting participants at this time. It was first listed on August 22nd 2018 and has been most recently updated on April 13th 2022."

Answered by AI

For what illness is Ketoconazole usually prescribed?

"Ketoconazole is a viable option to treat the fungal infections coccidioidomycosis, paracoccidioidomycosis, and tinea corporis caused by trichophyton mentagrophytes."

Answered by AI

What are the main aims of this clinical experiment?

"This study will measure the primary outcome of the proportion of patients with improved skin rash over a period of four weeks using Skindex-16. Secondary objectives include an evaluation of changes from baseline in total score and subscales for incidence of skin toxicity as measured by Skin Toxicity Assessment Tool (STAT) and Skindex-16, as well as evaluating any adverse events associated with ketoconazole via Fisher's exact test. Statistical analysis techniques such as t-tests, Wilcoxon rank sum tests, and linear mixed modeling are utilized to compare results between two arms."

Answered by AI

Is this research the inaugural study of its kind?

"Initially researched in 2004, sponsored by Sanofi, the first Ketoconazole trial involved 20 participants and was subsequently approved as a medication. Currently there are 10 different ongoing studies for this drug distributed across 3 nations and 23 cities."

Answered by AI

How many people are participating in this research endeavor?

"This medical experiment necessitates 80 qualified participants. Participants can be recruited from Regions Cancer Care Center in Saint Paul, Illinois and Carle Cancer Centre in Urbana, New york."

Answered by AI

Have other researchers explored the possibilities of Ketoconazole?

"First analyzed in 2004 at the Kansas City VAMC, Ketoconazole has been heavily studied since then with 19142 completed trials. There are presently 10 ongoing investigations taking place; of these many studies originate from Saint Paul, Illinois."

Answered by AI

In what locales is this medical experiment currently being conducted?

"Patients are being recruited from 8 different clinical trial sites, which include Saint Paul, Urbana and Saint Louis Park. For those interested in partaking in the study it would be wise to select a location close by so that travel is minimized if one decides to enroll."

Answered by AI
~4 spots leftby Mar 2025