NCT02395601已完成1 期
A Phase 1 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, in Patients With B-Cell Lymphomas
Constellation Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年3月最近更新:
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
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Frequency of Dose-limiting toxicities (DLTs)
研究概览
简要总结
First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.
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
- •Adults (aged ≥ 18 years)
- •Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Adequate hematological, renal, hepatic, and coagulation laboratory assessments
- •Must give written informed consent to participate in this study before the performance of any study-related procedure
排除标准
- •A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1
- •Treatment with proton pump inhibitors, H2 antagonists, or antacids
- •Achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
- •Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •Acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
- •New York Heart Association Class III or IV congestive heart failure
- •QTcF > 470 msec on the screening ECG
- •Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
- •A past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
- •Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
- •Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI 1205
- •Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-1205
- •Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-
- •Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-
- •Treatment with medications that are strong inhibitors of CYP3A4
- •Treatment with medications that are inducers of CYP3A4 enzymes
- •Treatment with medications that are known to carry a risk of Torsades de Pointes
- •Pregnant or lactating women
- •Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
- •Patients unwilling or unable to comply with this study protocol
研究组 & 干预措施
CPI-1205
Experimental
干预措施: CPI-1205 (Drug)
结局指标
主要结局
Frequency of Dose-limiting toxicities (DLTs)
时间窗: DLTs asessed during Cycle 1 (first 28 days on study)
Frequency of dose-limiting toxicities (DLTs) associated with CPI-1205 administration during the first cycle (first 28 days) of treatment
次要结局
- Pharmacokinetic parameters of CPI-1205: AUC(0-t), AUC(0-inf), AUCtau,ss, Tmax, Cmax, Ctrough, T1/2, Vd/F, CL/F(Assessed during cycle 1 (first 28 days on study); and on cycle 2, day 1)
- Frequency of adverse events(Assessed from Day 1 of Cycle 1 through 30 days after patient's last dose of study drug)
- Disease response assessment will be performed using the 2014 Lugano Response Criteria for Hodgkin and Non-Hodgkin Lymphoma(After every 2 cycles of treatment for the first 6 cycles, and after every 4 cycles thereafter)
- Pharmacodynamic effects of CPI-1205 in lymphoma tissue: changes in levels of the trimethylated form of lysine residue 27 on histone 3; changes in the expression of genes whose transcription may be altered by EZH2 inhibition(Assessed during cycle 1 (first 28 days on study))
- Pharmacodynamic effects of CPI-1205 in bone marrow and in skin: changes in global levels of the trimethylated form of lysine residue 27 on histone 3 (H3K27me3)(Assessed during cycle 1 (first 28 days on study))
研究者
研究点 (6)
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