NCT00419328已完成1 期
NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose
AGC Biologics S.p.A.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2005年3月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To verify safety of escalating doses of NGR-hTNF
研究概览
简要总结
The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.
详细描述
This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced solid tumors for the definition of an optimal biological
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old with proven advanced solid tumors not amenable to any clinical improvement by current standard treatments. Tumors recognized to be highly vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included.
- •ECOG Performance status 0 - 2
- •Patients may have had prior therapy providing the following conditions are met:
- •Chemo, radio, hormonal or immunotherapy: wash-out period of 28 days
- •Surgery: wash-out period of 14 days
- •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 metastases
- •AST and/or ALT < 5 x ULN in presence of liver metastases
- •Serum creatinine < 1.5 x ULN
- •Absence of any conditions in which hypervolemia 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
- •Patients must give written informed consent to participate in the study
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. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
研究组 & 干预措施
Experimental Arm A
Experimental
Patients were scheduled to receive a 1 hour intravenous (iv) infusion of NGR-hTNF every 3weeks.- The dose of administered NGR-hTNF was: 0.2, 0.4, 0.8, 1.6 μg/m2 (step 1); 3.2, 6.4, 12.8 μg/m2 (step 2); 19.2, 28.8, 43.2 64.8 μg/m2 (step 3); 86.2, 114.6, 152.4 μg/m2 (step 4)
干预措施: NGR-hTNF (Drug)
结局指标
主要结局
To verify safety of escalating doses of NGR-hTNF
时间窗: during and following the treatment
To verify safety of escalating doses of NGR-hTNF
次要结局
- To document possible modifications on vessels permeability(before and following the first treatment)
- To document signs of anticancer activity(every 6 weeks)
研究者
研究点 (1)
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