EUCTR2014-000579-20-DE进行中（未招募）1 期
A phase Ib, open-label, multicenter, dose escalation and expansion study, to evaluate the safety, pharmacokinetics and activity of INC280 in combination with cetuximab in c-MET positive CRC and HNSCC patients who have progressed after anti-EGFR monoclonal antibody therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female aged = 18 years
- •Metastatic colorectal cancer or head and neck squamous cell carcinoma
- •c-MET positive (defined by c-MET IHC intensity score +2 in = 50% of tumor cells and MET gene copy number = 5 by FISH or IHC intensity score +3 in = 50% of tumor cells) and K/NRAS-WT status for mCRC patients only
- •At least one previous line of treatment for the metastatic disease and the last treatment must have included cetuximab or panitumumab. Documentation of clinical benefit and subsequent progression on cetuximab or panitumumab as the most recent line of treatment is required for patients in the expansion part. Treatment with other anti-EGFR monoclonal antibodies (e.g. Nimotuzumab) can be accepted following discussion and agreement with Novartis
- •Measurable disease as per RECIST v1.1
- •ECOG performance status = 2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Prior treatment with c-MET/HGF inhibitors
- •History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia)
- •History of acute or chronic pancreatitis
- •Active bleeding within 4 weeks prior to screening visit
- •Symptomatic brain metastases
- •Feeding tube dependence
- •Not adequate hematologic, renal and hepatic function
研究者
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