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NCT00519285 · ClinicalTrials.gov registry record · Phase 3

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

A Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
1,224
Enrollment target
20
Study locations

NCT00519285: Completed Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis, sponsored by Sanofi.

NCT00519285 is a Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis that has completed, run by Sanofi. The registered enrollment target is 1,224 participants, above the 495-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (147% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00519285, a Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
1,224 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause. The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier.

Conditions Studied

Prostatic Neoplasms Neoplasm Metastasis

Interventions

  • DRUG Docetaxel
  • DRUG Prednisone or Prednisolone
  • DRUG Aflibercept
  • DRUG Placebo (for aflibercept)

Study Locations (20)

Other

  • 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

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Trial Details

FieldValue
Enrollment Target 1,224 participants
Start Date 2007-08
Est. Completion 2012-04
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00519285 record still lists

NCT00519285 is an interventional study that assigns participants to a tested intervention. Its 1,224 participants enrollment target places it among the larger protocols in the corpus, above the 495-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (147% higher).

The record links to 2 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT00519285 names 20 study sites across 2 states, led by Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00519285 about?

NCT00519285 is a clinical study titled "Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer". 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 placeb...

What is the current status of trial NCT00519285?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,224 participants. The study started on 2007-08. Estimated completion is 2012-04.

What conditions does trial NCT00519285 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Neoplasm Metastasis.

What interventions are being tested in trial NCT00519285?

The interventions under investigation include: Docetaxel (DRUG), Prednisone or Prednisolone (DRUG), Aflibercept (DRUG), Placebo (for aflibercept) (DRUG).

Who is sponsoring clinical trial NCT00519285?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00519285 being conducted?

This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostatic Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00519285's enrollment target sits among peer trials

1,224 8th of 65 higher than 58 of 65 other Prostatic Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00519285, the US trial registry maintained by the National Library of Medicine. NCT00519285 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.