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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Proportion of patients who report an improvement in skin rash
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient has a prior allergy or intolerance of ketoconazole
- •Patient has an allergy or intolerance to sulfites
研究组 & 干预措施
Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28.
干预措施: Ketoconazole (Drug)
Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28.
干预措施: Quality-of-Life Assessment (Other)
Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
Participants apply placebo topically BID on days 1-28.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Participants apply placebo topically BID on days 1-28.
干预措施: Placebo Administration (Other)
Arm II (placebo)
Participants apply placebo topically BID on days 1-28.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo)
Participants apply placebo topically BID on days 1-28.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Proportion of patients who report an improvement in skin rash
时间窗: 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.
次要结局
- Incidence of skin toxicity(Up to 4 weeks)
- Incidence of adverse events for ketoconazole(Up to 4 weeks)