Overview

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Aflibercept
Androgens
Docetaxel
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone