EUCTR2011-001988-52-IT进行中（未招募）不适用
Phase II clinical trial exploring the activity of crizotinib in patients with advanced solid tumors induced by causal alterations of specific receptors (ALK and MET/HGF receptor tyrosine kinases) expressed by cancer sells.
E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER0 个研究点目标入组 582 人开始时间: 2013年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 582
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Step 1 registration: *Local diagnosis of locally advanced and/or metastatic malignant tumor (defined befor) deemed incurable by conventional surgery, radiotherapy, systemic therapy or any other means.* Mandatory shipment of tumor-containing tissue blocks. Step 2 registration: *Measurable disease according to RECIST 1.1 with target lesion of at least 20mm (or 10mm on spiral CT scans). *Minimum age 15 years, no upper age limit. *Eastern Cooperative OncologyGroup (ECOG) performance status 0-2. *Adequate hematological function:ANC=1x109/L, platelets=30x109/L and hemoglobin=8g/dl. *Adequate renal function:serum creatinine =2xULN.*Adequeta liver function:Bilirubin =1.5xULN. AST and ALT=2.5xULN in the qbsence of liver metastases and =5xULN if liver function abnormalities are due to the underlying malignancy. *Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;those conditions should be discussed with the patient before registration in te trial. *Negative pregnancy test. *All patients (male and female) of childbearing/reproduxtive potential must use adequate birth control measures during the study treatment period and for at least three months after the last study tratment. *Written consent before registration. *Additional inclusion criteria linked to specific tumor type are described in the protocol in section 3.2
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Step 2 registration: *Carcinomatous meningitis or leptomeningeal disease. *Treatment zith any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug before tratment with crizotinib (whatever is the longest period). *Prior therapy directly targeting ALK and/or MET, previous tratment with crizotinib.*Previous and active malignancy for the last three years with the exception of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treatedbasal or squamous cell skin carcinoma. *Acute or chronic severe gastrointestinal conditions such as diarrhea or ulcer. *Current congestive heart failure. *Ongoing cardiac dysrhythmias of NCI CTCAE Grade >2. *Uncontrolled atrial fibrillation of any grade. *Pregnant women.
研究者
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