An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
450mg bid po
Cancer Hospital Affiliated to Shandong first medical University
Jinan, Shandong, China
RECRUITINGORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO
Time frame: from first dose to the last patient was followed up for 6 month
PFS
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),an average of about 1 year
DOR
Duration of response
Time frame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first),an average of about 1 year
OS
Overall survival
Time frame: from the first dose to the time of death due to any cause,an average of about 2 year
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