Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,224

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Prostatic NeoplasmsNeoplasm Metastasis
Interventions
DRUG

Aflibercept

"25 mg/ml solution~6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle"

DRUG

Placebo (for aflibercept)

"Sterile aqueous buffered solution identical to aflibercept~1-hour IV on Day 1 of each 3-Week cycle"

DRUG

Docetaxel

"Marketed formulation~75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)"

DRUG

Prednisone or Prednisolone

"Marketed formulation~5 mg twice daily PO from day 1 continuously"

Trial Locations (31)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Buenos Aires

Sanofi-Aventis Administrative Office, Macquarie Park

Sanofi-Aventis Administrative Office, Diegem

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Providencia Santiago

Sanofi-Aventis Administrative Office, City of Zagreb

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Hørsholm

Sanofi-Aventis Administrative Office, Tallinn

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Frankfurt

Sanofi-Aventis Administrative Office, Hong Kong

Sanofi-Aventis Administrative Office, Budapest

Sanofi-Aventis Administrative Office, Netanya

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, Gouda

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Porto Salvo

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Singapore

Sanofi-Aventis Administrative Office, Gauteng

Sanofi-Aventis Administrative Office, Seoul

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Bromma

Sanofi-Aventis Administrative Office, Geneva

Sanofi-Aventis Administrative Office, Taipei

Sanofi-Aventis Administrative Office, Istanbul

Sanofi-Aventis Administrative Office, Kiev

Sanofi-Aventis Administrative Office, Guildford Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY