This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation.
Objective response rate (ORR)
ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Duration of response (DoR)
DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Disease control rate (DCR)
DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Investigator evaluated ORR
the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Progression-free survival (PFS)
the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Overall survival (OS)
from the first date of Infigratinib treatment until date of death.
Time frame: from the first date of Infigratinib treatment until date of death.
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Center
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Hospital Lanzhou University
Lanzhou, Gansu, China
Dongguan City People's Hospital
Dongguan, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
...and 20 more locations