EUCTR2006-005700-14-IT进行中（未招募）不适用
GR007 A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic small cell lung carcinoma SCLC previously treated with no more than one therapeutic regimen - NGR007
MOLMED0 个研究点开始时间: 2007年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients 18 years affected by SCLC previously treated with no more than one therapeutic regimen Measurable disease according to RECIST criteria ECOG Performance status 0 2 Adequate baseline bone marrow, hepatic and renal function, defined as follows Neutrophils 1.5 x 109/L and platelets 100 x 109/L;Bilirubin 1.5 x ULN;AST and/or ALT 2.5 x ULN in absence of liver metastasis;AST and/or ALT 5 x ULN in presence of liver metastasis;Serum creatinine 1.5 x ULN Absence of any conditions in which hypervolaemia and its consequences e.g. increased stroke volume, elevated blood pressure or haemodilution could represent a risk for the patient reference appendix Technical data sheet human albumin Normal cardiac function and absence of uncontrolled hypertension written informed consent
- •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
- •Concurrent anticancer therapy Patients may not receive any other investigational agents while on study Clinical signs of CNS involvement Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol Pregnancy or lactation
研究者
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