Stopped: Business Reason
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 .
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Objective response rate (ORR)
Timeframe: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Duration of response (DoR)
Timeframe: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Disease control rate (DCR)
Timeframe: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Investigator evaluated ORR
Timeframe: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Progression-free survival (PFS)
Timeframe: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Overall survival (OS)
Timeframe: from the first date of Infigratinib treatment until date of death.