Ketokonazol vid behandling av deltagare med pågående EGFR-hämmare-inducerade utslag
Dubbelblind, placebokontrollerad studie för att utforska anti-androgen, ketokonazol, för behandling av patienter med en pågående epidermal tillväxtfaktorreceptor (EGFR) inhibitor-inducerad utslag
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Tidig fas 1
Kontakter och platser
Studieorter
-
-
Illinois
-
Danville, Illinois, Förenta staterna, 61832
- Carle on Vermilion
-
Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Förenta staterna, 55426
- Park Nicollet Frauenshuh Cancer Center
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
-
-
New York
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28. |
Correlative studies Ancillary studies
Andra namn:
Ancillary studies Applied topically
Andra namn:
|
|
Placebo-jämförare: Arm II (placebo)
Participants apply placebo topically BID on days 1-28. |
Correlative studies Ancillary studies
Andra namn:
Ancillary studies Applied topically |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of patients who report an improvement in skin rash
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of skin toxicity
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in PLA2G4D, PLOD2, and SALL4
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Aminah Jatoi, M.D., Mayo Clinic
- Huvudutredare: Elizabeth J. Cathcart-Rake, M.D., Mayo Clinic
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MC17C1
- MC17C1 (Annan identifierare: Mayo Clinic in Rochester)
- NCI-2018-00355 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- R01CA207183 (U.S.S. NIH-anslag/kontrakt)
- 17-007786 (Annan identifierare: Mayo Clinic Institutional Review Board)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .