지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2014.1
- 수록면
- 234 - 242 (9page)
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초록· 키워드
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PurposeThe purpose of this study is to determine the maximum tolerated dose (MTD), safety,pharmacokinetics, and recommended phase II dose of an oral drug composed of paclitaxeland HM30181A, which is an inhibitor of P-glycoprotein, in patients with advancedcancers.
Materials and MethodsPatients with advanced solid tumors received standard therapy were given the studydrug at escalating doses, using a 3+3 design. The study drug was orally administeredon days 1, 8, and 15, with a 28-day cycle of administration. The dose of paclitaxel wasescalated from 60 to 420 mg/m2, and the dose of HM30181A was escalated from30-210 mg/m2.
ResultsA total of twenty-four patients were enrolled. Only one patient experienced a doselimitingtoxicity—a grade 3 neutropenia that persisted for more than 2 weeks, at 240mg/m2 of paclitaxel. MTD was not reached. The maximum plasma concentration wasobtained at a dose level of 300 mg/m2 and the area under the curve of plasma concentration-time from 0 to the most recent plasma concentration measurement of paclitaxelwas reached at a dose level of 420 mg/m2. The absorption of paclitaxel tendsto be limited at doses that exceed 300 mg/m2. The effective plasma concentrationof paclitaxel was achieved at a dose of 120 mg/m2. Responses of 23 patients wereevaluated; 8 (34.8%) had stable disease and 15 (65.2%) had progressive disease.
ConclusionThe study drug appears to be well tolerated, and the effective plasma concentrationof paclitaxel was achieved. The recommended phase II dose for oral paclitaxel is 300mg/m2.
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참고문헌 (21)
참고문헌 신청
Baird RD / 2010 / Weekly paclitaxel in the treatment of recurrent ovarian cancer / Nat Rev Clin Oncol 7 : 575 ~ 582
Bocci G / 2002 / Protracted low-dose effects on human endothelial cell proliferation and survival in vitro reveal a selective antiangiogenic window for various chemotherapeu
Broker LE / 2007 / A phase I safety and pharmacologic study of a twice weekly dosing regimen of the oral taxane BMS-275183 / Clin Cancer Res 13 : 3906 ~ 3912
Cascorbi I / 2006 / Role of pharmacogenetics of ATP-binding cassette transporters in the pharmacokinetics of drugs / Pharmacol Ther 112 : 457 ~ 473
Hong YS / 2013 / A phase I study of DHP107, a mucoadhesive lipid form of oral paclitaxel, in patients with advanced solid tumors: crossover comparisons with intravenous pacli
Bocci G / 2002 / Protracted low-dose effects on human endothelial cell proliferation and survival in vitro reveal a selective antiangiogenic window for various chemotherapeu
Broker LE / 2007 / A phase I safety and pharmacologic study of a twice weekly dosing regimen of the oral taxane BMS-275183 / Clin Cancer Res 13 : 3906 ~ 3912
Cascorbi I / 2006 / Role of pharmacogenetics of ATP-binding cassette transporters in the pharmacokinetics of drugs / Pharmacol Ther 112 : 457 ~ 473
Hong YS / 2013 / A phase I study of DHP107, a mucoadhesive lipid form of oral paclitaxel, in patients with advanced solid tumors: crossover comparisons with intravenous pacli
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