- 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 treatment is required
for patients in the expansion part
- Measurable disease as per RECIST v1.1
- ECOG performance status 2
- Prior treatment with c-MET/HGF or EGFR inhibitors (with the exception of the last
- History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and
- 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
Other protocol-defined inclusion/exclusion criteria may apply NVS Definition: List only
the main study specific inclusion/exclusion criteria that patients will understand.
Note: DO NOT cut/paste directly from the protocol.
Do not include age and gender as part of this field. Age and gender are indicated in the 2
Always include statement "Other protocol-defined inclusion/exclusion criteria may apply"
at the end of this section.
Patients within 7- 42 days of an acute myocardial infarction associated with left
ventricular systolic dysfunction Qualifying Echocardiogram at Visit 1
Presence of clinically overt heart failure Percutaneous coronary intervention (PCI) less
than 24 hours before randomization previous treatment with aliskiren
Other protocol-defined inclusion/exclusion criteria may apply.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Frequency of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Overall Response Rate
Time versus plasma concentration profiles and basic PK parameters of INC280
Severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Frequency of dose treatment interruptions and reductions
Progression Free Survival