A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 55
- 试验地点
- 5
- 主要终点
- Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.
研究概览
简要总结
This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520.
The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting).
In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting).
In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (Active, not recruiting).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARRY-520
干预措施: ARRY-520, KSP(Eg5) inhibitor; intravenous (Drug)
ARRY-520 + G-CSF support
干预措施: ARRY-520, KSP(Eg5) inhibitor; intravenous (Drug)
ARRY-520 + G-CSF support
干预措施: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (Drug)
ARRY-520 + dexamethasone + G-CSF support
干预措施: ARRY-520, KSP(Eg5) inhibitor; intravenous (Drug)
ARRY-520 + dexamethasone + G-CSF support
干预措施: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (Drug)
ARRY-520 + dexamethasone + G-CSF support
干预措施: Dexamethasone, steroid; oral (Drug)
结局指标
主要结局
Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.
时间窗: Part 1
Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.
时间窗: Part 2 and Part 3
Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Part 3
次要结局
- Assess the efficacy of the study drug, with and without dexamethasone, in terms of duration of response, progression-free survival, treatment-free survival, time to next treatment and overall survival.(Part 2 and Part 3)
- Characterize the pharmacokinetics of the study drug.(Part 1)
- Assess the efficacy of the study drug in terms of response rate, duration of response, progression-free survival, treatment-free survival and time to next treatment.(Part 1)
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.(Part 2)
- Explore potential biomarkers for pharmacodynamics (PD) and for patient selection.(Part 1, Part 2 and Part 3)