Phase I safety and pharmacokinetic study of bevacizumab in Chinese patients with advanced cancer / 中华医学杂志(英文版)
Chinese Medical Journal
;
(24): 901-906, 2010.
Artigo
em Inglês
| WPRIM
| ID: wpr-242548
ABSTRACT
<p><b>BACKGROUND</b>bevacizumab is a humanized recombinant vascular endothelial growth factor (VEGF) monoclonal antibody, which specifically binds to VEGF and inhibits tumor cell growth, proliferation and metastasis. We aimed to investigate the safety and pharmacokinetics of bevacizumab in Chinese patients with advanced cancer.</p><p><b>METHODS</b>Thirty-nine Chinese patients with metastatic or relapsed cancers who failed prior therapy were enrolled in this phase I study of bevacizumab. Bevacizumab was infused by a calculated pump at doses from 5 mg/kg to 15 mg/kg in 90 minutes. Patients underwent serial pharmacokinetic evaluations. Patients that received at least one infusion of bevacizumab were included in the safety study.</p><p><b>RESULTS</b>Thirty-five patients finished all 5 infusions following protocol. One patient withdrew after 3 infusions due to grade 3 proteinuria. Common adverse events possibly related to the study drug were proteinuria (17/39, 43.6%), hypertension (13/39, 33.3%), gingival bleeding (7/39, 17.9%), epistaxis (6/39, 15.4%), pharyngeal inflammation (6/39, 15.4%), fatigue (6/39, 15.4%) and stomatitis (4/39, 10.3%). Bevacizumab pharmacokinetics was linear within the range of 5 mg/kg q2w--10 mg/kg q2w and 15 mg/kg q3w. CL (clearance), Vd (volume of distribution at elimination) and Vss (volume of distribution at steady state) were similar after single and multiple doses at 5, 10 and 15 mg/kg.</p><p><b>CONCLUSIONS</b>Bevacizumab is well tolerated in Chinese patients. No unexpected adverse events were observed. There is no racial difference in the pharmacokinetics.</p>
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Farmacocinética
/
Inibidores da Angiogênese
/
Usos Terapêuticos
/
Povo Asiático
/
Tratamento Farmacológico
/
Anticorpos Monoclonais Humanizados
/
Bevacizumab
/
Anticorpos Monoclonais
/
Neoplasias
Tipo de estudo:
Guia de Prática Clínica
Limite:
Adulto
/
Idoso
/
Feminino
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Chinese Medical Journal
Ano de publicação:
2010
Tipo de documento:
Artigo
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