Effect of Food on the Pharmacokinetics of Olaparib after Oral Dosing of the Capsule Formulation in Patients with Advanced Solid Tumors
作者: Christian RolfoHelen SwaislandKarin LeunenAnnemie RuttenPatricia SoetekouwSarah SlaterHenk M. W. VerheulAnitra FieldingKaren SoWendy BannisterEmma Dean
作者单位: 1University Hospital Antwerp
2Therakin Consulting
3University Hospitals Leuven
4Translational Cancer Research Group Antwerp
5Maastricht University Medical Center
6Cancer Research UK
7VU University Medical Center
10The Christie NHS Foundation Trust
刊名: Advances in Therapy, 2015, Vol.32 (6), pp.510-522
来源数据库: Springer Journal
DOI: 10.1007/s12325-015-0214-4
关键词: Food effectOlaparibOlaparib capsulePARP inhibitionPharmacokineticsPKPoly(ADP-ribose) polymerase (PARP) inhibitor
英文摘要: Abstract(#br) Background(#br)The oral, potent poly(ADP-ribose) polymerase (PARP) inhibitor, olaparib, is well tolerated at doses of ≤400 mg twice daily (BID) (administered as capsules), and has shown efficacy in patients with advanced BRCA -mutated ovarian and breast cancer.(#br) Methods(#br)This Phase I, open-label, randomized trial investigates the effect of food on the pharmacokinetics of olaparib in patients with refractory/resistant advanced solid tumors. In Part A, a three-period crossover study, patients received a single oral dose of olaparib 400 mg (8 × 50 mg capsules) in three prandial states: fasted, a high-fat meal or a standard meal (with a 5–14 day washout). Blood samples for pharmacokinetic (PK) assessments were taken pre-dose and up to 72 h post-dose. After completing Part...
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影响因子:2.125 (2012)

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