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Báo cáo y học: "Two-dose-level confirmatory study of the pharmacokinetics and tolerability of everolimus in Chinese patients with advanced solid tumors"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Two-dose-level confirmatory study of the pharmacokinetics and tolerability of everolimus in Chinese patients with advanced solid tumors. | Xu et al. Journal of Hematology Oncology 2011 4 3 http www.jhoonline.Org content 4 1 3 JOURNAL OF HEMATOLOGY ONCOLOGY RESEARCH Open Access Two-dose-level confirmatory study of the pharmacokinetics and tolerability of everolimus in Chinese patients with advanced solid tumors Rinnl Io Vi I1t Vil nnn A I2t I in Qinon2 rhitnc i A oi Vo4 Annatto hnna5 A77addina f lnoi fì5 Ml II A ntnm6 Bingne Au liLong wu Lin jnen Dingwei ie Annene Jappe Azzeddine Ciieni nui wang RuiRong Yuan7 Abstract Background This phase I randomized multicenter open-label study investigated the pharmacokinetics safety and efficacy of the oral mammalian target of rapamycin inhibitor everolimus in Chinese patients with advanced solid tumors. Methods A total of 24 patients with advanced breast cancer n 6 gastric cancer n 6 non-small cell lung cancer n 6 or renal cell carcinoma n 6 who were refractory to unsuitable for standard therapy were randomized 1 1 to oral everolimus 5 or 10 mg day. Primary end points were pharmacokinetic parameters and safety and tolerability. Pharmacokinetic 24-h profiles were measured on day 15 trough level was measured on days 2 8 15 16 and 22. Tolerability was assessed continuously. This final analysis was performed after all patients had received 6 months of study drug or had discontinued. Results Everolimus was absorbed rapidly median Tmax was 3 h range 1-4 and 2 h range 0.9-6 in the 5 and 10 mg day groups respectively. Pharmacokinetic parameters increased dose proportionally from the 5 and 10 mg day doses. Steady-state levels were achieved by day 8 or earlier. The most common adverse events suspected to be related to everolimus therapy were increased blood glucose 16.7 and 41.7 and fatigue 16.7 and 33.3 in the everolimus 5 and 10 mg day dose cohorts respectively. Best tumor response was stable disease in 10 83 and 6 50 patients in the 5 and 10 mg day groups respectively. Conclusions Everolimus 5 or 10 mg day was well tolerated in Chinese patients with advanced solid .