A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

Summary

Primary Objective: * To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors. Secondary Objectives: * To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel * To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination * To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease * To evaluate the immunogenicity of IV aflibercept * To measure endogenous free Vascular Endothelial Growth Factor (VEGF)

Timeline

Start

2010-07

Primary completion

2011-09

Completion

2011-12

Publications

• Huang Y, Zou BY, Zhao LP, Zhao HY, Zhao YY, Xue C, Zhang JW, Xu F, Chen LK, Liu JL, Hu ZH, Wu X, Zhang J, Ma YX, Wei CL, Ma Y, Zhang L. Phase I dose-escalation study of aflibercept plus docetaxel in nasopharyngeal carcinoma and other solid tumors. Future Oncol. 2014 Dec;10(16):2579-91. doi: 10.2217/fon.14.206.

Drugs

Indications