METBEIGE 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: 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 :
Dosage and Administration for Investigational material : -
Primary outcome(s): safety
efficacy
- Proportion of subjects with DLT (phase 1 part)
- Confirmed ORR by investigators’ assessment in patients who received study treatment as 3rd line or later (phase 2 part)
Study Design: An open-label, single arm phase I study and an open-label, randomized controlled multicenter phase II study