NCT00964873已完成1 期
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
研究概览
简要总结
An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
- •ECOG Performance Status 0-2
- •Adequate organ function as defined in the protocol.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Hyperleukocytosis
- •Acute Promyelocytic Leukemia (FAB-M3) subtype
- •Uncontrolled Disseminated Intravascular Coagulation (DIC)
- •Active central nervous system leukemia
- •Concomitant radiation therapy, chemotherapy, or immunotherapy
- •Women who are pregnant or lactating
- •Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
- •Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life
- •Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these molecules
- •Use of any investigational agents within two weeks or within six times the agent's half life --Treatment with chronic immunosuppressants
- •Other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.
研究组 & 干预措施
1 Part 1
Experimental
干预措施: STA-9090 (ganetespib) (Drug)
结局指标
主要结局
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
时间窗: every 8 weeks
次要结局
- To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML(ongoing)
研究者
相似试验
已完成
1 期
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative DisordersCMLMDSMyeloproliferative DisordersAMLNCT00858572Synta Pharmaceuticals Corp.31
Unknown
1 期
Study of STA-9090, Administered Twice-Weekly in Patients With Solid TumorsSolid TumorsNCT00688116Synta Pharmaceuticals Corp.45
已完成
1 期
Study of STA-9090, Administered Once-Weekly in Patients With Solid TumorsSolid TumorsNCT00687934Synta Pharmaceuticals Corp.53
已完成
2 期
A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)Non Small Cell Lung CancerNCT01031225Synta Pharmaceuticals Corp.113
已完成
1 期
STA-9090 in Patients With Advanced Hepatocellular CancerHepatocellular CarcinomaNCT01665937Massachusetts General Hospital16