Overview

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.