A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 13
- 主要终点
- Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
研究概览
简要总结
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).
In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (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 (Schedule 1) + bortezomib + G-CSF
干预措施: ARRY-520, KSP(Eg5) inhibitor; intravenous (Drug)
ARRY-520 (Schedule 1) + bortezomib + G-CSF
干预措施: Bortezomib, proteasome inhibitor; intravenous or subcutaneous (Drug)
ARRY-520 (Schedule 1) + bortezomib + G-CSF
干预措施: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (Drug)
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF
干预措施: ARRY-520, KSP(Eg5) inhibitor; intravenous (Drug)
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF
干预措施: Bortezomib, proteasome inhibitor; intravenous or subcutaneous (Drug)
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF
干预措施: Dexamethasone, steroid; oral (Drug)
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF
干预措施: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (Drug)
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF
干预措施: ARRY-520, KSP(Eg5) inhibitor; intravenous (Drug)
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF
干预措施: Bortezomib, proteasome inhibitor; intravenous or subcutaneous (Drug)
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF
干预措施: Dexamethasone, steroid; oral (Drug)
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF
干预措施: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (Drug)
结局指标
主要结局
Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
时间窗: Part 1
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Part 1
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response
时间窗: Part 2
次要结局
- Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.(Part 2)
- Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment.(Part 1 and Part 2)
- Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.(Part 2)