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A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Biomarker/Laboratory analysis, Treatment


Active


18 and over


Pharmaceutical / Industry


EFC10261
AVE0005, EudraCT 2007-000819-29, NCT00532155

Trial Description

Summary

The primary objective of the study is to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives are to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this patient population and to determine immunogenicity of IV aflibercept (anti- aflibercept antibody detection) in all patients.

Eligibility Criteria

Inclusion Criteria:

  • Histological/cytological proven locally advanced or metastatic non-small cell lung cancer
  • Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate renal, liver and bone marrow functions

Exclusion Criteria:

  • Squamous histology/cytology
  • Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
  • Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow
  • Prior docetaxel treatment
  • Uncontrolled hypertension

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

Regeneron Pharmaceuticals

ICDStudy Director

Public Registry ICD
  Email: GV-Contact-us@sanofi-aventis.com

Trial Sites

U.S.A.
New Jersey
  Bridgewater
 Sanofi-Aventis Administrative Office
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Argentina
  San Isidro
 Sanofi-Aventis Administrative Office
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Australia
  Macquarie Park New South Wales
 sanofi-aventis Australia & New Zealand administrative office
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Austria
  Vienna
 Sanofi-Aventis Austria
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Brazil
  Sao Paulo
 Sanofi-Aventis Brazil
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Canada
  Laval
 Sanofi-Aventis Canada
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Chile
  Providencia
 Sanofi-Aventis Administrative Office
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
China
  Shangaï
 Sanofi-Aventis China
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Czech Republic
  Praha
 Sanofi-Aventis Czech Republic
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Estonia
  Tallinn
 Sanofi-Aventis Estonia
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Finland
  Helsinki
 Sanofi-Aventis Finland
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
France
  Paris
 Sanofi-Aventis France
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Germany
  Berlin
 Sanofi-Aventis Germany
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Greece
  Athens
 Sanofi-Aventis Greece
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Hong Kong
  Causeway Bay
 Sanofi-Aventis Hong Kong
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Hungary
  Budapest
 Sanofi-Aventis Hungary
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
India
  Mumbai
 Sanofi-Aventis India
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Italy
  Milano
 Sanofi-Aventis Italy
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Netherlands
  Gouda
 Sanofi-Aventis Netherlands
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Poland
  Warszawa
 Sanofi-Aventis Poland
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Republic of Bulgaria
  Sofia
 Sanofi-Aventis Bulgaria
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Republic of Korea
  Seoul
 Sanofi-Aventis South Korea
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Republic of Singapore
  Singapore
 Sanofi-Aventis Singapore Private Limited
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Romania
  Bucuresti
 Sanofi-Aventis Romania Limited
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Russia
  Moscow
 Sanofi-Aventis Russia
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Spain
  Barcelona
 Sanofi-Aventis Spain - Barcelona
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Sweden
  Bromma
 Sanofi-Aventis Sweden
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Turkey
  Istanbul
 Sanofi-Aventis Turkey
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
United Kingdom
  Guildford
 Sanofi-Aventis United Kingdom
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00532155
Information obtained from ClinicalTrials.gov on August 22, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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