NCT00532155 - A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer | Biotech Hunter

Enrollment

913

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

January 31, 2011

Study Completion Date

October 31, 2011

Conditions

CarcinomaNon Small Cell Lung

Interventions

DRUG

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.

DRUG

Placebo

Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.

DRUG

Docetaxel (Taxotere®)

75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.

DRUG

Dexamethasone (pre- and post-medication for docetaxel)

As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).

Trial Locations (32)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Buenos Aires

sanofi-aventis Australia & New Zealand administrative office, Macquarie Park

Sanofi-Aventis Administrative Office, Vienna

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Sofia

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Santiago

Sanofi-Aventis Administrative Office, Shanghai

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Tallinn

Sanofi-Aventis Administrative Office, Helsinki

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Athens

Sanofi-Aventis Administrative Office, Causeway Bay

Sanofi-Aventis Administrative Office, Budapest

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, Kuala Lumpur

Sanofi-Aventis Administrative Office, Gouda

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Porto Salvo

Sanofi-Aventis Administrative Office, Bucharest

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Singapore

Sanofi-Aventis Administrative Office, Seoul

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Bromma

Sanofi-Aventis Administrative Office, Taipei

Sanofi-Aventis Administraive Office, Istanbul

Sanofi-Aventis Admnistrative Office, Guildford Surrey