Phase 1 dose-escalation and pharmacokinetic study of regorafenib in paediatric patients with recurrent or refractory solid malignancies

Birgit Geoerger,Bruce Morland,Irene Jiménez,Didier Frappaz,Andrew D J Pearson,Gilles Vassal,Patricia Maeda,Jasmine Kincaide,Udo Mueller,Sarah Schlief,Michael Teufel,Bart A Ploeger,Adriaan Cleton, Andrea C Agostinho,Lynley V Marshall

European Journal of Cancer（2021）

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摘要

•Regorafenib had acceptable tolerability in paediatric patients.•The recommended phase 2 dose (RP2D) in paediatric patients was 82 mg/m2.•Exposure at the RP2D was comparable with adult exposure at the standard 160 mg/day.•Preliminary antitumour activity supports further studies in paediatric patients.•Regorafenib treatment downregulated circulating target proteins c-KIT and VEGFR2.

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关键词

Regorafenib,Solid tumour,Paediatric,Phase 1,Pharmacokinetics

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