Neoplasm Malignant Clinical Trial
Official title:
A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies
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)
The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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