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Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

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ClinicalTrials.gov Identifier: NCT03471364
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Skin Burning Sensation Skin Rash Drug: Ketoconazole Other: Laboratory Biomarker Analysis Other: Placebo Other: Quality-of-Life Assessment Other: Questionnaire Administration Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28.
Drug: Ketoconazole
Applied topically
Other Names:
  • Fungarest
  • Fungoral
  • Ketoderm
  • Ketoisdin
  • Nizoral
  • Orifungal M
  • Panfungol
  • R-41400
  • Xolegel

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Placebo Comparator: Arm II (placebo)
Participants apply placebo topically BID on days 1-28.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Applied topically
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Proportion of patients who report an improvement in skin rash assessed by Skindex-16 [ Time Frame: Up to 4 weeks ]
    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.


Secondary Outcome Measures :
  1. The change from baseline in total score and subscales for incidence of skin toxicity as measured by the Skindex-16 [ Time Frame: Up to 4 weeks ]
    Responses to the Skindex-16 will be categorized into three subscales: symptom, emotional, and functional. Analysis of the total scales and subscales of the Skindex-16 will involve a t-test and Wilcoxon rank sum procedures (as appropriate) at each time point as well as linear mixed modeling. Descriptive factors will be used as covariates in the modeling analysis. The change from baseline in the total score and subscales of the Skindex-16 will be compared between two arms by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), a non-parametric procedure such as Wilcoxon rank sum will be used.

  2. The change from baseline in the total score and subscales of the incidence of skin toxicity as measured by the Skin Toxicity Assessment Tool (STAT) [ Time Frame: Up to 4 weeks ]
    Responses to the STAT will be categorized into three subscales: symptom, emotional, and functional. Analysis of the total scales and subscales of the STAT will involve a t-test and Wilcoxon rank sum procedures (as appropriate) at each time point as well as linear mixed modeling. Descriptive factors will be used as covariates in the modeling analysis. The change from baseline in the total score and subscales of the STAT will be compared between two arms by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), a non-parametric procedure such as Wilcoxon rank sum will be used.

  3. Incidence of adverse events for ketoconazole [ Time Frame: Up to 4 weeks ]
    Adverse events will be tabulated by treatment arm. Frequencies of various types of adverse events (AEs) will be compared using Fisher?s exact test. Will explore the difference in reliability of the direct versus (vs.) indirect AE attribution approaches in the placebo arm.


Other Outcome Measures:
  1. Change in PLA2G4D, PLOD2, and SALL4 assessed by ribonucleic acid (RNA) sequencing [ Time Frame: Baseline up to 4 weeks ]
    Will explore the association between baseline/change in PLA2G4D, PLOD2, and SALL4 with rash improvement. Baseline gene expression level and change from baseline in gene expression level for the androgen-related genes such as PLA2G4D, PLOD2, and SALL4 will be compared between arms by t-test and Wilcoxon rank sum procedures (as appropriate). Mixed Models for Logistic Regression will also be implemented to explore the association between PLA2G4D, PLOD2, and SALL4 with rash improvement by adjusting the baseline gene expression level and change from baseline in gene expression levels for each gene. Descriptive factors will be used as covariates in the modeling analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471364


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Aminah Jatoi, M.D.         
Park Nicollet Frauenshuh Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Grant Simonson, BA, MA Bioethics    952-993-6723    Grant.simonson@parknicollet.com   
Principal Investigator: Dylan Zylla, M.D.         
Regions Cancer Care Center Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Grant Simonson, BA, MA Bioethics    952-993-6723    Grant.simonson@parknicollet.com   
Principal Investigator: Dylan Zylla, M.D.         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 146142
Contact: Nicholas Gerbino, BS    585-273-2605    Nicholas_Gerbino@URMC.Rochester.edu   
Principal Investigator: Richard Dunne, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aminah Jatoi Mayo Clinic

Additional Information:
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03471364     History of Changes
Other Study ID Numbers: MC17C1
NCI-2018-00355 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC17C1 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors