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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; Docetaxel

Criteria

Inclusion criteria :

• Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.

Exclusion criteria :

• Squamous histology/cytology lung cancer

• Need for a major surgical procedure or radiation therapy during the study

• Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days

• Cumulative radiation therapy to >25% of the total bone marrow

• History of brain metastases

• Eastern Cooperative Oncology Group(ECOG)>1

• Prior docetaxel treatment but have not been appropriate for safety reasons

• Inadequate organ and bone marrow function

• Uncontrolled hypertension

• Evidence of clinically significant bleeding diathesis or underlying coagulopathy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.