EUCTR2007-005091-13-GB进行中（未招募）1 期
Phase II study of sorafenib in malignant mesothelioma previously treated with platinum-based chemotherapy - SMS
Guy's & St Thomas' NHS Foundation Trust0 个研究点目标入组 55 人开始时间: 2007年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- •1) Malignant pleural or peritoneal mesothelioma previously treated with first line platinum-based chemotherapy (prior pemetrexed not required);
- •2) Not suitable for radical resection. Prior radical or cytoreductive surgery allowed;
- •3) Age >18 years;
- •4) ECOG performance status 0-2;
- •5) Measurable disease. Lesions must be measured by CT scan or MRI according to modified RECIST (Appendix B);
- •6) Life expectancy of at least 12 weeks;
- •7) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
- •a) haemoglobin = 9.0 g/dL
- •b) neutrophil count = 1.5 x109/L
- •c) platelet count = 100 x109/L
- •d) total bilirubin = 1.5 x upper limit of normal
- •e) ALT and AST = 2.5 x upper limit of normal (= 5 x upper limit of normal for patients with liver involvement)
- •f) alkaline phosphatase = 4 x upper limit of normal
- •g) PT-INR (international normalized ratio of PT) / PTT =1.5 x upper limit of normal;
- •8) Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Excluded medical conditions:
- •1) History of cardiac disease: congestive heart failure > NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); or uncontrolled hypertension (defined as systolic blood pressure >150mmHg or diastolic pressure >90mmHg despite optimal medical management);
- •2) Impaired immunity or chronic infection including history of HIV (human immunodeficiency virus) infection or chronic hepatitis B or C;
- •3) Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0);
- •4) Seizure disorder requiring medication (such as steroids or anti-epileptics);
- •5) Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis;
- •6) History of organ allograft;
- •7) Evidence or history of bleeding diathesis or coagulopathy;
- •8) Renal dialysis;
- •9) Cancer other than mesothelioma within 5 years prior to start of study treatment EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumours [Ta (noninvasive tumour), Tis (carcinoma in situ) & T1 (tumour invading lamina propria)];
- •10) Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months;
- •11) Pulmonary haemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug;
- •12) Any other haemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug;
- •13) Serious, non-healing wound, ulcer, or bone fracture;
- •14) Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate;
- •15) Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results;
- •16) Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- •17) Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study;
- •18) Patients unable to swallow oral medications;
- •19) Any malabsorption condition.
研究者
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