A Phase 1b Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Anti-Tumor Activity of an Alternative Liquid Formulation of ACY-1215 (Ricolinostat) In Combination With Pomalidomide and Low-Dose Dexamethasone In Patients With Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Determine Maximum Tolerated Dose (MTD) if any, and recommended dose schedule
研究概览
简要总结
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ACY-1215 (ricolinostat) in combination with pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma.
详细描述
To determine the maximum tolerated dose (MTD), if present, and to identify a recommended dose and schedule of ricolinostat administered in an alternative liquid formulation (ALF) (10mg/mL) in combination with pomalidomide and low-dose dexamethasone in patients with relapsed or relapsed-and-refractory multiple myeloma.
To evaluate the safety and any anti-tumor activity of ricolinostat administered in combination with pomalidomide and dexamethasone as treatment for patients with relapsed or relapsed-and-refractory multiple myeloma, including duration of response.
To assess the Pharmacokinetics and Pharmacodynamics of all three medications administered in combination, and to assess the Pharmacokinetics of ricolinostat and pomalidomide specifically. An evaluation of the relationship between response and biomarkers relating to interacellular acetylation may also be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation Cohort
Dose Escalating Cohorts of ACY-1215 in combination with pomalidomide and dexamethasone.
干预措施: ACY-1215 in combination with pomalidomide and dexamethasone (Drug)
结局指标
主要结局
Determine Maximum Tolerated Dose (MTD) if any, and recommended dose schedule
时间窗: Every 56 days on treatment, estimated average of 4 months.
Identify the MTD of ACY-1215 administered in an alternative liquid formulation (ALF) if present, and identify a recommended dose and schedule. Patients will be followed for completion of 6 28-day Cycles of Study Treatment (for ITT Population analysis).
次要结局
- Anti-Tumor Activity(Upon completion of a 28-day treatment cycle and for the duration of treatment, an estimated average of 4 months.)
- Pharmacokinetics(Up to 8 days post first dose)
- Pharmacodynamics(Up to 24 hours post first dose)
- Safety(Upon completion of a 28-day treatment cycle and for the duration of treatment, an estimated average of 4 months.)