Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET. - CREATE

EORTC0 个研究点目标入组 582 人开始时间: 2013年4月18日最近更新: 2017年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: EORTC
入组人数: 582

研究概览入排标准研究者记录与标识符相似试验

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 before) 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 20 mm (or 10 mm on spiral CT scans).
•Minimum age 15 years, no upper age limit.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•Adequate hematological function: ANC = 1 x 109/L, platelets = 30 x 109/L and hemoglobin = 8 g/dl.
•Adequate renal function: serum creatinine = 2 x ULN.
•Adequate liver function: Bilirubin = 1.5 x ULN. AST and ALT = 2.5 x ULN in the absence of liver metastases and = 5 x UNL 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 the trial.
•Negative pregnancy test
•All patients (male and female) of childbearing/reproductive potential must use adequate birth control measures during the study treatment period and for at least three months after the last study treatment
•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 with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug before treatment with crizotinib (whatever is the longest period).
•Prior therapy directly targeting ALK and/or MET, previous treatment 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 treated basal 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

发起方

EORTC

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