Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Measurable disease as per RECIST v1.1
ECOG performance status ≤ 2
You may not be if
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
Clareo Health | Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy
