NCT00483080已完成2 期
NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens
AGC Biologics S.p.A.3 个研究点 分布在 1 个国家目标入组 46 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
- 46
- 试验地点
- 3
- 主要终点
- 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 colorectal cancer 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 colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, 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 80 Years（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 colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy
- •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 < 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 hemodilution 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
- •More than three lines of chemotherapy (except biological agents)
- •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
A: 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
Progression Free Survival (PFS)
时间窗: during the study
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
次要结局
- to evaluate AUC(tau) of NGR-hTNF in patients treated with weekly schedule(during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start))
- Tumor Growth Control Rate (TGCR)(during the study)
- Overall survival (OS)(during the study)
- Circulating tumor cells (CTCs)(before and following the treatment)
- Experimental imaging study (DCE-MRI)(before and following the first cycle)
- to evaluate Cmax of NGR-hTNF in patients treated with weekly schedule(during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start))
- Safety according to NCI-CTCAE criteria (version 3)(during and following the treatment)
研究者
研究点 (3)
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