NCT02362048已完成2 期
A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
研究概览
简要总结
ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men and women ≥ 18 years of age
- •ECOG performance status of 0 or 1
- •Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
- •Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy
排除标准
- •Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years.
- •Known central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction
- •Breastfeeding or pregnant
研究组 & 干预措施
Experimental: Arm 1
Experimental
ACP-196 alone
干预措施: ACP-196 (Drug)
Experimental: Arm 2
Experimental
ACP-196 in combination with pembrolizumab
干预措施: ACP-196 in combination with pembrolizumab (Drug)
结局指标
主要结局
Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
时间窗: Every 12 weeks for up to 2 years.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
未报告次要终点
研究者
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