An Investigator-initiated Trial to Evaluate the Efficacy and Safety of JAK Inhibitor Cream for the Treatment of EGFR-inhibitor-induced Skin Rash
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of grade 0 or 1 patients at Week 4
研究概览
简要总结
Epidermal growth factor receptor inhibitors (EGFRIs) are widely used targeted agents that have been approved for the treatment of various tumor types. In some clinical studies with EGFRIs, the incidence of dermatology AE, the skin rash, is reportedly as high as 95%, which profoundly impact the patients' quality of life. However no treament for onset skin rash has been approved to be effective by any clinical trial yet. Janus kinase (JAK) inhibitor, has been approved for or studied in a variety of skin conditions such as alopecia areata, atopic dermatitis, and psoriasis. Thus the investigators intend to evaluate the efficacy and safety of JAK inhibitor cream for the treatment of EGFRIs-induced skin rash in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older.
- •Pathologically confirmed cancer receiving EGFRI-based therapy (monotherapy or as part of a combination therapy regimen).
- •Skin rash causally related to EGFRI therapy of grade 1 or higher (according to MESTT criteria).
- •ECOG performance score <
- •Able to use topical medications and complete questionnaires reliably with or without assistance.
- •Life expectancy of greater than 6 months.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Use of any other topical medications in the treatment areas (face) within 7 days prior to randomization or duing the study.
- •Use of Tetracycline (e.g. minocycline, doxycycline) within 14 days prior to randomization or duing the study.
- •Use of other cancer medications known to result in skin rash in the face or upper chest/upper back area within 4 weeks prior to randomization or duing the study.
- •Known hypersentitivity to JAK inhibitors.
- •With other skin disorders that may affect efficacy evaluation, including but not limited to: eczema, psoriasis, etc.
- •Uncontrolled intercurrent illness.
- •Significantly abnormal lab test.
- •Pregnant or nursing women.
研究组 & 干预措施
Cream containing JAK Inhibitor
干预措施: Cream containing JAK Inhibitor (Drug)
结局指标
主要结局
Proportion of grade 0 or 1 patients at Week 4
时间窗: 4 weeks
Determine the proportion of patients receiving JAK Inhibitor Cream who have achieved 1 or 2 grade(s) decrease in skin rash (according to MASCC EGFR Inhibitor Skin Toxicity Tool - the MESTT criteria for Papulopustular Eruption, which includes 4 grades, Grade 3 as the most severe condition and Grade 0 as no symptom) at Week 4
次要结局
- Proportion of grade 0 or 1 patients at Week 2(2 weeks)
- Proportion of grade 0 or 1 patients at Week 6(6 weeks)
- Change of PRO (FACT-EGFR 14) from baseline at Week 4(4 weeks)
- Safety of study drug(6 weeks)