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Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

NCT00519285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1224

Last updated 2016-07-22

Study results available
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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.

Conditions

  • Prostatic Neoplasms
  • Neoplasm 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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2012-04-30
Completion
2012-04-30

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

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00519285 on ClinicalTrials.gov