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

NCT01148615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-01-13

No results posted yet for this study

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)

Conditions

  • Neoplasm Malignant

Interventions

DRUG

Aflibercept (AVE0005)

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Docetaxel (XRP6976)

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148615 on ClinicalTrials.gov