NCT00519285

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,224 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were: * To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL); * To assess the overall safety in both treatment arms; * To determine the pharmacokinetics of intravenous (IV) aflibercept in this population; * to determine immunogenicity of IV aflibercept.

Detailed description

The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first. The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.

Conditions

• Prostatic Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2007-08-22
• Last updated: 2016-07-22
• Results posted: 2013-10-10

Locations

31 sites across 31 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom