A Study of ARRY-520 in Patients With Advanced Cancer
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
- 2
- 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 Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.
This study has two parts. In the first part, patients with advanced solid tumors 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 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed).
In the second part of the study, 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 15 patients from the US will be enrolled in Part 2 (Completed).
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
- •Histological or cytological evidence of malignancy.
- •Advanced solid tumors that have recurred or progressed following standard therapy(ies).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Adequate hematology counts and serum chemistry values.
- •Additional criteria exist.
排除标准
- •Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
- •Major surgery within 28 days prior to the first dose of study drug.
- •Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to <5% of the bone marrow).
- •Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
- •Additional criteria exist.
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)
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
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Part 1 and Part 2
次要结局
- Assess the efficacy of the study drug in terms of tumor response.(Part 1 and Part 2)
- Characterize the pharmacokinetics of the study drug.(Part 1 and Part 2)