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

ovartis Farmacéutica, S.A.0 个研究点目标入组 60 人开始时间: 2014年6月9日最近更新: 2016年5月23日

适应症

试验速览

暂无简介。

•1. Male or female aged greater than or equal to 18 years.
•2. Metastatic colorectal cancer or head and neck squamous cell carcinoma.
•3. c-MET positive (defined by c-MET IHC intensity score +2 or +3 in greater than or equal to 50% of tumor cells) and K/NRAS-WT status for mCRC patients only.
•4. 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 treatment is required for patients in the expansion part.
•5. Measurable disease as per RECIST v1.1.
•6. 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

•1. Prior treatment with c-MET/HGF or EGFR inhibitors (with the exception of the last treatment).
•2. History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia).
•3. History of acute or chronic pancreatitis.
•4. Active bleeding within 4 weeks prior to screening visit.
•5. Symptomatic brain metastases.
•6. Feeding tube dependence.
•7. Not adequate hematologic, renal and hepatic function.

发起方

ovartis Farmacéutica, S.A.