進行中のEGFR阻害剤誘発性発疹のある参加者の治療におけるケトコナゾール
上皮成長因子受容体（EGFR）阻害剤による発疹が進行中の患者を治療するための抗アンドロゲン剤であるケトコナゾールを探索するための二重盲検プラセボ対照試験
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
Illinois
-
Danville、Illinois、アメリカ、61832
- Carle on Vermilion
-
Urbana、Illinois、アメリカ、61801
- Carle Cancer Center
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
-
Saint Louis Park、Minnesota、アメリカ、55426
- Park Nicollet Frauenshuh Cancer Center
-
Saint Paul、Minnesota、アメリカ、55101
- Regions Hospital
-
-
New York
-
Rochester、New York、アメリカ、14642
- University of Rochester
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28. |
Correlative studies Ancillary studies
他の名前：
Ancillary studies Applied topically
他の名前：
|
|
プラセボコンパレーター：Arm II (placebo)
Participants apply placebo topically BID on days 1-28. |
Correlative studies Ancillary studies
他の名前：
Ancillary studies Applied topically |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of patients who report an improvement in skin rash
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of skin toxicity
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in PLA2G4D, PLOD2, and SALL4
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Aminah Jatoi, M.D.、Mayo Clinic
- 主任研究者：Elizabeth J. Cathcart-Rake, M.D.、Mayo Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MC17C1
- MC17C1 (その他の識別子：Mayo Clinic in Rochester)
- NCI-2018-00355 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- R01CA207183 (米国 NIH グラント/契約)
- 17-007786 (その他の識別子：Mayo Clinic Institutional Review Board)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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