CTRI/2008/091/000042Other3 期
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:
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
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
研究点 (5)
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