A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 210
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.
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
- •≥ 18 years of age;
- •Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;
- •An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
排除标准
- •Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);
- •Patients with overt leptomeningeal leukemia or CNS lymphoma;
- •Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x ULN;
- •Inadequate renal function defined by serum creatinine > 1.5 x ULN
研究组 & 干预措施
IPI-145
IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles.
干预措施: IPI-145 (duvelisib) (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: At least 28 days (1 Cycle)
To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.
次要结局
未报告次要终点