NCT02345408已完成1 期
An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.
详细描述
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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 non-resectable pancreatic adenocarcinoma with or without metastases
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
- •Anticipated life expectancy ≥ 12 weeks
- •Radiographically measurable disease acc. to RECIST 1.1
- •Use of adequate contraception (as described in protocol)
- •Ability to provide written informed consent and comply with study requirements
排除标准
- •Received other cancer treatment or investigational drug within 4 weeks prior to screening
- •Women who are pregnant or breastfeeding
- •Had major surgery within 4 weeks of first dose of study drug
- •Inadequate liver, renal or bone marrow function within 2 weeks of first dose
- •Serious concurrent illness, altered medical status or any uncontrolled medical condition
- •Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
- •Known active HIV, HBV or HCV infection
- •Inability to swallow tablets
- •History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation
研究组 & 干预措施
CCX872-B
Experimental
150 mg once or twice daily given orally for at least 12 weeks
干预措施: CCX872-B (Drug)
结局指标
主要结局
progression-free survival
时间窗: 24 weeks
subject incidence of Grade 3 or 4 adverse events
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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