Spots Global Cancer Trial Database for A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

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Trial Identification

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

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

Study ID: NCT01148615

Conditions

Neoplasm Malignant

Interventions

Aflibercept (AVE0005)

Docetaxel (XRP6976)

Study Description

Brief 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)

Detailed Description: 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.