NCT01148615

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	Aflibercept (AVE0005)	Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUG	Docetaxel (XRP6976)	Pharmaceutical form: solution for infusion Route of administration: intravenous

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2010-06-22
• Last updated: 2012-01-13

Locations

1 site across 1 country: China