NCT02112526已完成1 期
An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
研究概览
简要总结
To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Men and women ≥ 18 years of age.
- •Pathologically confirmed de novo ABC DLBCL
- •Relapsed or refractory disease
- •Subjects must have ≥ 1 measurable disease sites
排除标准
- •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
- •Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 50%
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- •Breast feeding or pregnant
研究组 & 干预措施
Acalabrutinib
Experimental
干预措施: Acalabrutinib (Drug)
结局指标
主要结局
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
时间窗: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
次要结局
- Maximum Observed Plasma Concentration (Cmax)(1 Cycle (28 days))
- Area Under the Plasma Concentration (AUC)(1 Cycle (28 days))
- Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)(2 Cycles (1 cycle = 28 days) and at end of treatment)
- Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)(From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days))
研究者
研究点 (1)
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