Abstract:
BACKGROUND/AIM:The phosphatidylinositol-3-kinase (PI3K) signaling pathway is frequently activated in cancer. Buparlisib (BKM120), an oral pan-PI3K inhibitor, inhibits proliferation of human cancer in preclinical models. Studies of buparlisib in Western and Japanese adults with advanced solid tumors established a recommended dose of 100 mg/day and showed an acceptable safety profile and evidence of efficacy. This phase I dose-escalation/expansion study aimed to establish the maximum tolerated dose (MTD) of single-agent, once daily oral buparlisib in Chinese patients with advanced solid tumors. MATERIALS AND METHODS:Patients (n=32; primary tumor site: lung (n=15), breast (n=10) or head and neck (n=7); ≥2 prior lines of antineoplastic therapy (n=26)) received 80 mg (n=15) or 100 mg (n=17) daily buparlisib. RESULTS:Five patients experienced dose-limiting toxicities: grade (G)3 depression (n=1), G2 hyperglycemia (n=3) and G3 hyperglycemia (n=1). Most frequent buparlisib-related adverse events were hyperglycemia (n=18; 56%), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increase (n=9; 28%), as well as anxiety (n=6; 19%); most common buparlisib-related G3/4 adverse events: hyperglycemia (n=3; 9%), ALT and AST increase (n=2; 6%), as well as gamma-glutamyltransferase increase (n=2; 6%). Best response was stable disease (SD) in 10 patients (31%). CONCLUSION:The MTD of buparlisib was declared as 100 mg/day. Safety, efficacy and pharmacokinetic data from this study were similar to those previously reported in Western and Japanese populations.
journal_name
Anticancer Resjournal_title
Anticancer researchauthors
Wu YL,Zhang LI,Trandafir L,Dong T,Duval V,Hazell K,Xu Bdoi
10.21873/anticanres.11212subject
Has Abstractpub_date
2016-11-01 00:00:00pages
6185-6194issue
11eissn
0250-7005issn
1791-7530pii
36/11/6185journal_volume
36pub_type
杂志文章abstract::The chromosomes were studied by an in vitro technique in four parametrial and one gastric leiomyomas. The findings in parametrial myomas (the present four cases and one published earlier) differed from the observations in uterine cases by the absence of normal stemlines and the absence of 1p,6p and 7q changes. As has ...
journal_title:Anticancer research
pub_type: 杂志文章
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journal_title:Anticancer research
pub_type: 杂志文章
doi:
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journal_title:Anticancer research
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doi:
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journal_title:Anticancer research
pub_type: 杂志文章
doi:
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journal_title:Anticancer research
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journal_title:Anticancer research
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