Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Median Overall Survival
研究概览
简要总结
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.
详细描述
PRIMARY OBJECTIVE:
I. Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib.
SECONDARY OBJECTIVES:
I. Determine the effects of this drug on quantities of circulating tumor cells in these patients.
II. Determine the time to progression in patients treated with this drug. III. Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Metastatic disease
- •Measurable or evaluable/nonmeasurable disease
- •No known brain metastases
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •Absolute granulocyte count >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •Hemoglobin > 8.5 g/dL
- •Bilirubin =< 1.5 times upper limit of normal (ULN)
- •AST and ALT =< 2.5 times ULN
- •Creatinine =< 2.0 mg/dL
- •Not pregnant or nursing
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
- •No QTc prolongation (i.e., QTc interval >= 480 msecs [Fridericia correction]) or other significant ECG abnormalities
- •LVEF normal by MUGA scan
- •No condition that impairs ability to swallow and retain dasatinib tablets, including any of the following:
- •Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- •Prior surgical procedures affecting absorption
- •Active peptic ulcer disease
- •No clinically significant cardiovascular disease, including any of the following:
- •Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- •Major conduction abnormality (unless a cardiac pacemaker is present)
- •Recovered from all prior therapy
- •More than 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin C) and/or radiotherapy
- •No prior chemotherapy for metastatic disease
- •More than 4 weeks since prior EGFR inhibitors (e.g., imatinib mesylate, gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
- •No prior EGFR inhibitors that target Src kinases
- •At least 7 days since prior and no concurrent agents with proarrhythmic potential
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent grapefruit or grapefruit juice
- •No other concurrent anticancer agents or therapies
- •No concurrent systemic antacids (i.e., H2-receptor antagonists and proton pump inhibitors) [Locally acting antacids (e.g., Maalox, Mylanta) allowed within either 2 hours before or 2 hours after dasatinib therapy]
- •No concurrent uncontrolled illness, including, but not limited to, any of the following:
- •Ongoing or active infection
- •History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders
- •Large pleural effusions
- •Psychiatric illness or social situation that would preclude study compliance
- •More than 7 days since prior and no concurrent CYP3A4 inducers or inhibitors
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
干预措施: dasatinib (Drug)
Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
干预措施: laboratory biomarker analysis (Procedure)
Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
干预措施: physiologic testing (Procedure)
结局指标
主要结局
Median Overall Survival
时间窗: assessed up to 24 months
From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months
次要结局
- Median Progression Free Survival (PFS)(Up to 5 years)
- Gait Speed(at 8 weeks)
- Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee(Up to 5 years)