Phase 2 Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-advanced Pancreatic Cancer

Otsuka Pharmaceutical Development & Commercialization, Inc.0 个研究点目标入组 200 人开始时间: 2011年5月23日最近更新: 2015年7月10日

适应症

试验速览

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•Inclusion Criteria
•Histologic or cytologic documentation of adenocarcinoma of the pancreas
•Unresectable disease due to local extension or invasion, for example:
•- Tumor extension precluding resection, eg, to
•mesenteric or retroperitoneal structures,vascular
•encasement, etc, or
•- Lymph node involvement beyond the surgical field
•Recovery from toxicity of previous procedures that establish diagnosis of locally-advanced disease (patients with previous pancreatic resection are excluded)
•ECOG PS 0 or 1
•Adequate organ function:
•- Absolute neutrophil count = 1,500/µL
•- Platelet count = 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: 0
•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

•Exclusion Criteria
•Evidence of metastatic disease based on symptoms, laboratory values, or imaging studies = 21 days prior to the first dose of IMP
•Previous radiotherapy or chemoradiotherapy
•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
•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
•Clinically significant bleeding disorder or coagulopathy (eg, von Willebrand’s disease)
•Requirement for a concomitant medication that is a strong inhibitor of Cytochrome P450 (CYP) 3A4

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