NCT00801294已完成2 期
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 46
- 主要终点
- The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks
研究概览
简要总结
The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •Signed informed consent.
- •Histologically proven colorectal adenocarcinoma
- •History or presence of metastatic colorectal cancer (stage IV)
- •Measurable (>1 cm) or evaluable tumour deposit (according to RECIST criteria)
- •Documented progression or unacceptable toxicity on the last therapy
- •Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
- •Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
- •If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
- •If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
- •Life expectancy of at least 12 weeks.
- •WHO (ECOG) performance status <= 2, <= 1 if age > 75 years.
- •Adequate hepatic function
- •Adequate renal function
排除标准
- •Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
- •Treatment with standard chemotherapy or cetuximab within the last 14 days
- •Treatment with bevacizumab within the last 28 days
- •History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
- •Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
- •Significant cardiovascular diseases
- •History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
- •Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
- •Pregnancy or breast-feeding
结局指标
主要结局
The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks
时间窗: every 4 weeks
PFS
时间窗: 16 weeks
次要结局
- Progression-free survival (based on the RECIST criteria)(66 Weeks)
- Overall survival(66 Weeks)
- Effectiveness of dose reduction guidelines in managing adverse events(66 Weeks)
- The incidence and intensity of Adverse Events with grading of Adverse Events according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0)(66 Weeks)
- Changes in safety laboratory parameters(66 Weeks)
研究者
研究点 (46)
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