EUCTR2014-000579-20-BE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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