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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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Medical and Biotech [MESH] Definitions

A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Abnormal growths of tissue that follow a previous neoplasm but are not metastases of the latter. The second neoplasm may have the same or different histological type and can occur in the same or different organs as the previous neoplasm but in all cases arises from an independent oncogenic event. The development of the second neoplasm may or may not be related to the treatment for the previous neoplasm since genetic risk or predisposing factors may actually be the cause.

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A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)

A general term for a malignant neoplasm derived from muscular tissue. (Stedman, 25th ed)

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