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

2014-08-27 03:12:44 | BioPortfolio

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)

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Neoplasm Malignant

Intervention

Aflibercept (AVE0005), Docetaxel (XRP6976)

Location

Sanofi-Aventis Administrative Office
Shangai
China

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:44-0400

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