期刊
EUROPEAN JOURNAL OF CANCER
卷 39, 期 7, 页码 917-926出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0959-8049(03)00057-1
关键词
phase I clinical trial; angiogenesis inhibitor; integrins; Cilengitide (EMD 121974); pharmacology
类别
A single-agent dose escalating phase I and pharmacokinetic study with Cilengitide, an inhibitor of the integrins alphavbeta3 and alphavbeta5, was performed to determine its safety and toxicity. Cilengitide was administered as a one-hour infusion twice weekly without interruption to patients with histologically- or cytologically-con finned metastatic solid tumours. Plasma pharmacokinetics were determined at days I and 15. 37 patients were enrolled into the study. Dose levels studied were 30, 60, 120, 180, 240, 400, 600, 850, 1200, and 1600 mg/m(2)/infusion. There was no dose-limiting toxicity (DLT). Pharmacokinetics were dose-independent and time-invariant. Apparent terminal half-life ranged from 3 to 5 h. At 120 mg/m(2)/infusion, peak plasma concentrations were attained that optimally inhibited tumour growth in preclinical models. Cilengitide can be safely administered using a continuous twice-weekly infusion regimen. As DLT was not reached, future trials should explore Cilengitide at different doses. (C) 2003 Elsevier Science Ltd. All rights reserved.
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