A Phase 2 interventional study of Infigratinib in Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by LianBio LLC. Terminated at 30 sites in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by LianBio LLC · Phase 2, Interventional, and Treatment
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 .
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's enrollment of 6 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →LianBio LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Infigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg.
Drug: Infigratinib
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.
Also known as: BGJ398, BBP-831
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.
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Infigratinib
LianBio LLC