CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,224 enrolled
Drug / intervention
Aflibercept +3 moredrug
Likely dose
Aflibercept 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00519285
NCT00519285Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Aug 22, 2007·Updated Jul 22, 2016

In Brief

A Phase 3 clinical trial evaluating Aflibercept, Placebo (for aflibercept), and 2 other interventions for Prostatic Neoplasms and Neoplasm Metastasis. Completed, enrolled 1,224 participants across 31 sites in 31 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms, Neoplasm Metastasis
CountriesArgentina, 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, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 22, 2007
Enrollment StartAug 1, 2007
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 18.9 years ago

Interventions

Afliberceptdrug

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

Placebo (for aflibercept)drug

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

Docetaxeldrug

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

Prednisone or Prednisolonedrug

Marketed formulation 5 mg twice daily PO from day 1 continuously