Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Macroscopic evaluation of tumour response
研究概览
简要总结
Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its interactions play an important role in the SCC pathogenesis and represent a good therapeutic target from these tumours.
Primary Objectives:
To evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK).
Secondary Objectives:
- To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period.
- To investigate the molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables.
- Trial with medicinal product
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lapatinib
干预措施: Lapatinib (Drug)
结局指标
主要结局
Macroscopic evaluation of tumour response
时间窗: 84 days
The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).
次要结局
- Evaluation of tolerability(84 days)
- Molecular evaluation of tumour response(84 days)