EUCTR2010-024595-26-IT进行中（未招募）不适用
Phase 2 Placebo-controlled Double-Blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-Advanced Pancreatic Cancer
OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC0 个研究点目标入组 200 人开始时间: 2011年9月5日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female subjects = 18 years of age.
- •2.Histologic or cytologic documentation of adenocarcinoma of the pancreas.
- •3.Unresectable disease due to local extension or invasion, for example:
- •?Tumor extension precluding resection, eg, mesenteric or retroperitoneal structures, vascular encasement, etc, or
- •?Lymph node involvement beyond the surgical field.
- •4.Recovery from toxicity of previous procedures that establishes diagnosis of locally advanced disease (patients with previous pancreatic resection are excluded)
- •5.ECOG PS 0 or 1
- •6.Adequate organ function:
- •- Absolute neutrophil count = 1,500/µL
- •- Platelets = 100,000/µL
- •- Bilirubin = 2.0 X upper limit of normal (ULN)
- •- Creatinine = 1.5 mg/dL
- •- Aspartate transaminase = 2.5 X ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1.Evidence of metastatic disease based on symptoms, laboratory values, or imaging studies = 21 days prior to the first dose of IMP
- •2.Previous radiotherapy or chemoradiotherapy
- •3.History of or current pleural effusion (any cause, = Grade 1) within 6 months prior to the first dose of IMP. An equivocal finding at the costophrenic angle is allowed
- •4.History of significant cardiovascular disease or the following events within 6 months prior to the first dose of IMP: coronary infarction, life-threatening arrhythmia, or QTc prolongation > 470 ms
- •5.Clinically significant bleeding disorder or coagulopathy (eg, von Willebrand’s disease)
- •6.Requirement for a concomitant medication that is a strong inhibitor of Cytochrome P450 (CYP) 3A4
研究者
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