A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients 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 see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Completed).
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Florida
-
Tampa、Florida、美国、33612
- Moffitt Cancer Center
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory University, Winship Cancer Institute
-
-
Ohio
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic
-
-
Texas
-
Houston、Texas、美国、77030
- MD Anderson Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria (Part 1 and Part 2):
- Diagnosis of MDS by bone marrow biopsy.
- International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
- May have received prior therapy for MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Adequate liver and renal function.
- Additional criteria exist.
Key Exclusion Criteria (Part 1 and Part 2):
- History of bone marrow transplant.
- Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
- Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
- Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have prolonged side effects.
- Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
- Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
- Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
- Additional criteria exist.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：艾瑞-614
|
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Establish the maximum tolerated dose (MTD) of study drug.
大体时间：Part 1, 9 months
|
Part 1, 9 months
|
|
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
大体时间：Part 1, 9 months; Part 2, 9 months
|
Part 1, 9 months; Part 2, 9 months
|
|
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
大体时间：Part 1, 9 months; Part 2, 9 months
|
Part 1, 9 months; Part 2, 9 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.
大体时间：Part 1, 9 months; Part 2, 9 months
|
Part 1, 9 months; Part 2, 9 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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