NCT00483093已完成1 期
NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor
AGC Biologics S.p.A.2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks
研究概览
简要总结
The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).
详细描述
This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.
Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.
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 with advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and suitable for a treatment with cisplatin
- •Life expectancy more than 3 months
- •ECOG Performance status 0-1
- •Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) may represent a risk for the patient
- •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
- •Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
- •Patients may have had prior therapy providing the following conditions are met:
- •Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days
- •Corticosteroid therapy wash out period of 14 days
- •Surgery: wash-out period of 14 days
- •Patients must give written informed consent to participate in the study
排除标准
- •Previous signs of severe toxicity platinum related
- •Patients must not receive any other investigational agents while on study
- •New York Heart Association class III or IV cardiac disease
- •Unstable angina
- •Patients with myocardial infarction within the last six (6) months
- •Patient with significant peripheral vascular disease
- •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
A
Experimental
干预措施: NGR-hTNF (Drug)
A
Experimental
干预措施: Cisplatin (Drug)
结局指标
主要结局
To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks
时间窗: To recommend a dose regimen of NGR-hTNF + Cisplatin for future phase II trials
次要结局
- To document the preliminary antitumor activity of the combination in terms of objective response rate according to RECIST criteria(every six weeks)
- To evaluate the pharmacokinetic profiles of the combination of NGR-hTNF and cisplatin(During the study)
- To measure plasma levels of sTNFRs and anti-NGR-hTNF antibodies(During the study)
研究者
研究点 (2)
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