EUCTR2006-005993-39-IT进行中（未招募）不适用
GR010: A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen - NGR010
MOLMED0 个研究点开始时间: 2007年5月15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 malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen ?Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed ?Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy ?ECOG Performance status 0 ? 2 ?Adequate baseline bone marrow, hepatic and renal function, defined as follows: -Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/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 hypervoleamia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference ?Technical data sheet human albumin? specifically used in Pharmacy Department for NGR-hTNF dilution) ?Patients may have had prior therapy providing the following conditions are met: -Chemotherapy and radiotherapy: wash-out period of 28 days -Surgery: wash-out period of 14 days ?Normal cardiac function and absence of uncontrolled hypertension ?Patients must give written informed consent to participate in the study
- •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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