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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,224 participants |
| Start Date | 2007-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00519285
The ClinicalTrials.gov registry entry for NCT00519285 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,224 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 495-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (147% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.