Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostatic Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00519285

Run by

Sanofi

People needed

1224

Starts

2007-08-01

Expected to finish

2012-04-01

Last updated by the study team

2016-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically- or cytologically-confirmed prostate adenocarcinoma;
• Metastatic disease;
• Progressive disease while receiving hormonal therapy or after surgical castration;
• Effective castration.

You may not qualify if…

• Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago;
• Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF receptor inhibitors;
• Eastern Cooperative Oncology Group (ECOG) performance status >2.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Macquarie Park, Australia
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Providencia Santiago, Chile
• Sanofi-Aventis Administrative Office — City of Zagreb, Croatia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Frankfurt, Germany
• Sanofi-Aventis Administrative Office — Hong Kong, Hong Kong
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Porto Salvo, Portugal
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Singapore, Singapore
• Sanofi-Aventis Administrative Office — Gauteng, South Africa
• Sanofi-Aventis Administrative Office — Seoul, South Korea
• Sanofi-Aventis Administrative Office — Barcelona, Spain

Full record on ClinicalTrials.gov

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