NCT00484211已完成2 期
NGR008: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC) Previously Treated With no More Than One Systemic Therapeutic Regimen
AGC Biologics S.p.A.3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Antitumour activity defined as progression free survival (PFS)
研究概览
简要总结
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single agent.
Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria
详细描述
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic Hepatocellular Carcinoma (HCC) previously treated with no more than one systemic therapeutic regimen, that will be conducted using Simon's two-stage design method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 affected by advanced or metastatic HCC previously treated with no more than one systemic therapeutic regimen
- •Histologically confirmed HCC not amenable to curative surgery
- •Child-Pugh scale class A
- •ECOG Performance status 0 - 1
- •Patients in progression disease at study entry CT documented
- •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 < 2 x ULN
- •Transaminases < 3 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
- •Patients must give written informed consent
- •Exclusion criteria:
- •Decompensated cirrhosis (Child-Pugh score >7)
- •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
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
干预措施: NGR-hTNF (Drug)
结局指标
主要结局
Antitumour activity defined as progression free survival (PFS)
时间窗: during the study
次要结局
- Tumor growth control rate (TGCR) according to WHO criteria(during the study)
- Pharmacokinetics in patients treated with weekly schedule(during treatment)
- Safety(during the study)
- Overall survival (OS)(During the treatment and during the follow-up)
- Experimental imaging study (DCE-MRI)(During the treatment)
研究者
研究点 (3)
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