METBEIGE biomarker study

Interventions: investigational material(s)
Generic name etc : Cabozantinib Malate
INN of investigational material : Cabozantinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Cabozantinib (administered in the main study): 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
Primary outcome(s): pharmacogenomics
Analyses will be performed of the following parameters using formalin-fixed and paraffin-embedded (FFPE) specimens and freshly frozen specimens prepared from tumor tissue collected for the METBEIGE study (before protocol treatment, before the start of the second cycle, and after discontinuation of protocol treatment) and blood specimens collected at the same time.
The results obtained from the analyses will be integrated with clinical data obtained in the METBEIGE study to identify biomarkers of the effectiveness of the protocol treatment.
1)Analysis of cancer-related genetic abnormalities
2)Protein expression analysis
3)RNA expression analysis
4)Analysis of cancer cell lines and organoids
5)Patient-derived Xenografts (PDX) analysis
Study Design: exploratory research