Prostate Cancer Clinical Trial
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Histologically- or cytologically-confirmed prostate adenocarcinoma;
Metastatic disease;
Progressive disease while receiving hormonal therapy or after surgical castration;
Effective castration.
Exclusion Criteria:
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.
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There is 1 Location for this study
Bridgewater New Jersey, 08807, United States
Buenos Aires , , Argentina
Macquarie Park , , Australia
Diegem , , Belgium
Sao Paulo , , Brazil
Laval , , Canada
Providencia Santiago , , Chile
City of Zagreb , , Croatia
Praha , , Czech Republic
Horsholm , , Denmark
Tallinn , , Estonia
Paris , , France
Frankfurt , , Germany
Hong Kong , , Hong Kong
Budapest , , Hungary
Natanya , , Israel
Milan , , Italy
Seoul , , Korea, Republic of
Gouda , , Netherlands
Warsaw , , Poland
Porto Salvo , , Portugal
Moscow , , Russian Federation
Singapore , , Singapore
Gauteng , , South Africa
Barcelona , , Spain
Bromma , , Sweden
Geneva , , Switzerland
Taipei , , Taiwan
Istanbul , , Turkey
Kiev , , Ukraine
Guildford Surrey , , United Kingdom
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