NCT00484276已完成2 期
NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen
AGC Biologics S.p.A.4 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2007年5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
- 57
- 试验地点
- 4
- 主要终点
- Antitumor 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 malignant pleural mesothelioma 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 malignant pleural mesothelioma 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
- 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 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 hypervolemia 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
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
NGR-hTNF
Experimental
NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly
干预措施: NGR-hTNF (Drug)
结局指标
主要结局
Antitumor activity defined as progression free survival (PFS)
时间窗: during the study
Defined as the time from the date of randomization until disease progression, or death
次要结局
- Tumor Growth Control Rate (TGCR)(Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD)
- Overall survival (OS)(from the randomization until to the date of patient death or discontinuation from the study)
- Experimental Imaging Study (DCE-MRI)(During the treatment)
- Cmax of NGR-hTNF in patients treated with weekly schedule(During the treatment)
- AUC(tau) of NGR-hTNF in patients treated with weekly schedule(During the treatment)
- Safety according to NCI-CTCAE criteria (version 3)(During the treatment and during the follow-up)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung CarcinomaSmall Cell Lung CancerNCT00483509AGC Biologics S.p.A.28
已完成
2 期
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT00484211AGC Biologics S.p.A.40
已完成
2 期
Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)Colorectal Cancer (CRC)NCT00483080AGC Biologics S.p.A.46
已完成
2 期
NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung CancerNon-small Cell Lung CancerNCT00994097AGC Biologics S.p.A.121
已完成
2 期
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian CancerOvarian CancerNCT01358071AGC Biologics S.p.A.119