Spots Global Cancer Trial Database for Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
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Trial Identification
Brief Title: Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Official Title: 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
Study ID: NCT00519285
Study Description
Brief 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.
Detailed Description: The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first. The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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, Sao 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, Praha, , Czech Republic
Sanofi-Aventis Administrative Office, Horsholm, , 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, Natanya, , Israel
Sanofi-Aventis Administrative Office, Milan, , Italy
Sanofi-Aventis Administrative Office, Seoul, , Korea, Republic of
Sanofi-Aventis Administrative Office, Gouda, , Netherlands
Sanofi-Aventis Administrative Office, Warsaw, , Poland
Sanofi-Aventis Administrative Office, Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office, Moscow, , Russian Federation
Sanofi-Aventis Administrative Office, Singapore, , Singapore
Sanofi-Aventis Administrative Office, Gauteng, , South Africa
Sanofi-Aventis Administrative Office, Barcelona, , Spain
Sanofi-Aventis Administrative Office, Bromma, , Sweden
Sanofi-Aventis Administrative Office, Geneva, , Switzerland
Sanofi-Aventis Administrative Office, Taipei, , Taiwan
Sanofi-Aventis Administrative Office, Istanbul, , Turkey
Sanofi-Aventis Administrative Office, Kiev, , Ukraine
Sanofi-Aventis Administrative Office, Guildford Surrey, , United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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