A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer

SanofiSynthelabo India Limited5 个研究点分布在 1 个国家目标入组 630 人开始时间: 2008年9月18日最近更新: 2018年10月30日

试验速览

阶段: 3 期
状态: Other
发起方
入组人数: 630
试验地点: 5
主要终点: Overall Survival (OS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Trial will be conducted in 24 countries all over the world The Indian target - 25 patients Indian status - No patients randomized till date Planned date of first enrolment - April 2008

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•"1.Cytologically or histologically confirmed evidence of epithelial cancer (adenocarninoma) of the exocrine pancreas 2.Metastatic disease 3.No prior chemotherapy for pancreatic disease 4.ECOG performance status (PS) 0, 1 or 2 5.Adequate renal, liver and bone marrow functions ".

排除标准

•Less than 42 days elapsed from prior major surgery (28 days from other orior surgery) to the time of randomization
•Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
•Uncontrolled hypertension
•Pregnancy or breastfeeding
•Patient with reproductive potential (M/F) without effective method of contraception ".

结局指标

主要结局

Overall Survival (OS)

时间窗: From the first randomization until the end of study data cutoff date (approximately 2 years)

次要结局

Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and, in selected centers the pharmacokinetics of aflibercept.

研究者

发起方

SanofiSynthelabo India Limited

申办方类型

Pharmaceutical industry-Global

研究点 (5)

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