Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
研究概览
简要总结
The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
详细描述
Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Advanced solid malignancy
- •minimum age 18 years
- •indication for palliative treatment
- •measurable disease with at least one lesion accessable for biopsy
排除标准
- •Cardiovascular conditions including congestive heartfailure NYHA class >2
- •recent myocardial infarction or uncontrolled coronary artery disease
- •cardiac arrhythmias requiring anti-arrhythmic therapy
- •uncontrolled hypertension
- •uncontrolled infections
- •serious non-healing wound, ulcer or bone fracture
- •pregnant or breast feeding
研究组 & 干预措施
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Sunitinib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Sorafenib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Vemurafenib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Erlotinib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Everolimus (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Lapatinib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Dasatinib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: Pazopanib (Drug)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: tumor biopsy (Procedure)
Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
干预措施: skin biopsy (optional) (Procedure)
结局指标
主要结局
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
时间窗: 2 weeks
次要结局
- To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue(2 weeks)
- To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue(2 weeks)
- kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment(2 weeks)
- intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment(2 weeks)
研究者
M. Labots
Medical Oncologist
Amsterdam UMC, location VUmc