Ketokonazol i behandling av deltakere med pågående EGFR-hemmer-indusert utslett
Dobbeltblindet, placebokontrollert forsøk for å utforske antiandrogenet, ketokonazol, for behandling av pasienter med en pågående epidermal vekstfaktorreseptor (EGFR) inhibitor-indusert utslett
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Danville, Illinois, Forente stater, 61832
- Carle on Vermilion
-
Urbana, Illinois, Forente stater, 61801
- Carle Cancer Center
-
-
Minnesota
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Forente stater, 55426
- Park Nicollet Frauenshuh Cancer Center
-
Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital
-
-
New York
-
Rochester, New York, Forente stater, 14642
- University of Rochester
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
- 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 a prior allergy or intolerance of ketoconazole
- Patient has an allergy or intolerance to sulfites
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28. |
Correlative studies Ancillary studies
Andre navn:
Ancillary studies Applied topically
Andre navn:
|
|
Placebo komparator: Arm II (placebo)
Participants apply placebo topically BID on days 1-28. |
Correlative studies Ancillary studies
Andre navn:
Ancillary studies Applied topically |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients who report an improvement in skin rash
Tidsramme: Up to 4 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of skin toxicity
Tidsramme: Up to 4 weeks
|
As measured by the Skindex-16. 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. |
Up to 4 weeks
|
|
Incidence of skin toxicity
Tidsramme: Up to 4 weeks
|
As measured by the Skin Toxicity Assessment Tool (STAT). 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. |
Up to 4 weeks
|
|
Incidence of adverse events for ketoconazole
Tidsramme: 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. |
Up to 4 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in PLA2G4D, PLOD2, and SALL4
Tidsramme: Baseline up to 4 weeks
|
Assessed by ribonucleic acid (RNA) sequencing. 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. |
Baseline up to 4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Aminah Jatoi, M.D., Mayo Clinic
- Hovedetterforsker: Elizabeth J. Cathcart-Rake, M.D., Mayo Clinic
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MC17C1
- MC17C1 (Annen identifikator: Mayo Clinic in Rochester)
- NCI-2018-00355 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- R01CA207183 (U.S. NIH-stipend/kontrakt)
- 17-007786 (Annen identifikator: Mayo Clinic Institutional Review Board)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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