NCT02402036终止2 期
Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study
适应症
干预措施
相关药物
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
- Serum microRNA Quantification
研究概览
简要总结
This is an exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.
详细描述
Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for protein, miRNA, and mutated DNA analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Metastatic colorectal cancer suitable for regorafenib treatment
- •Life expectancy of at least 12 weeks
- •Able to understand and willing to sign written informed consent form
- •Adequate bone marrow, liver, and renal function
- •Glomerular filtration rate >/= 60 according to the Modified Diet in Renal Disease abbreviated formula
- •Women of childbearing potential must have a negative serum pregnancy test
- •Subject able to swallow and retain oral medication
排除标准
- •Previous assignment to treatment in this study
- •Uncontrolled hypertension
- •Active or clinically significant cardiac disease
- •Evidence or history of Bleeding diathesis or coagulopathy
- •Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of study medication
- •Subjects with thrombotic, embolic, venous or arterial events
- •Subjects with any previously untreated or concurrent cancer
- •Pheochromocytoma
- •Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
- •Ongoing infection Grade 2 or higher
- •Symptomatic metastatic brain or meningeal tumors
- •Presence of a non-healing wound, non-healing ulcer, or bone fracture
- •Renal failure requiring dialysis
- •Dehydration Grade 1 or higher
- •Seizure disorder requiring medication
- •Persistent proteinuria Grade 3 or higher
- •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
- •Pleural effusion or ascites that causes respiratory compromise
- •History of organ allograft including corneal transplant
- •Known or suspected allergy or hypersensitivity to the study drug
- •Any malabsorption condition
- •Women who are pregnancy or breast-feeding
- •Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- •Concurrent anticancer therapy
- •Concurrent use of another investigational drug or device therapy during or within 4 weeks of trial entry
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
- •Therapeutic anticoagulation with Vitamin-K antagonists or with heparins and heparinoids
- •Use of any herbal remedy
研究组 & 干预措施
Regorafenib
Experimental
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
干预措施: Regorafenib (Drug)
结局指标
主要结局
Serum microRNA Quantification
时间窗: 2 years
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
次要结局
未报告次要终点
研究者
研究点 (1)
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