Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Ki67 Tumor Proliferation Biomarker
研究概览
简要总结
Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.
We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.
Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.
Thus, it may reduce BCC growth in humans.
详细描述
Participants with at least one BCC tumor measuring 4 mm or greater in diameter will be enrolled onto 1 of 2 treatment cohorts to receive oral itraconazole.
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Cohort A - 400 mg itraconazole (as 200 mg twice daily for 30 days), stratified by:
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Cohort A1 - Participants are vismodegib-naive.
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Cohort A2 - Participants had received prior vismodegib treatment.
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Cohort B - 200 mg itraconazole (as 100 mg twice daily, for up to 4 months). The objective of this cohort is to assess the anti-cancer efficacy of lower-dose extended treatment.
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Control Group - Tumors from untreated participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A - Itraconazole 400 mg
Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, stratified by prior vismodegib history
干预措施: Itraconazole (Drug)
Cohort B - Itraconazole 200 mg
Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months
干预措施: Itraconazole (Drug)
结局指标
主要结局
Ki67 Tumor Proliferation Biomarker
时间窗: 1 month
Percent change in Ki67 tumor proliferation biomarker was assessed at baseline and after 1 month of treatment, for Cohort A1 (vismodegib-naïve participants receiving 400 mg as 200 mg twice daily) vs control patients. The outcome is expressed as the % change from baseline of cells with a positive signal after staining for Ki67. * Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients, \& is reported as the mean of the changes observed for those lesions for which both baseline and treated valued are available. * Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients, and is reported as the change in mean of the group of baseline basal cell carcinoma (BCC) lesion measurements and the group of treated BCC lesion measurements.
次要结局
- Change of GLI1 Tumor Biomarker(1 month)
- Tumor Size(Up to 3 months)
- Tumor Response(End of treatment period: 1 month (Cohort A) or 2.3 months (mean for Cohort B))
研究者
Jean Yuh Tang
Associate Professor of Dermatology
Stanford University