NCT01031225已完成2 期
A Non-Randomized, Open-label, Multi-Center, Multi-Cohort Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 21
- 主要终点
- Progression Free Survival rate
研究概览
简要总结
This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
- •Availability of tissue for analysis
- •ECOG Performance Status 0 or 1
- •Adequate organ function as defined in the protocol.
- •Must be at least 18 years old and able and willing to sign a written informed consent document
排除标准
- •Poor venous access requiring an indwelling catheter for study drug administration
- •Women who are pregnant or lactating
- •Ventricular ejection fraction < or = to 55% at baseline
- •Any uncontrolled intercurrent illness
研究组 & 干预措施
1
Experimental
干预措施: STA 9090 (Drug)
结局指标
主要结局
Progression Free Survival rate
时间窗: 16 weeks
次要结局
- Safety and tolerability as measured by adverse event rates and laboratory evaluations(16 months)
- Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival(18 months)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
1 期
A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous LeukemiaBlast-phase Chronic Myelogenous LeukemiaALLCMLAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaAMLNCT00964873Synta Pharmaceuticals Corp.29
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 Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal TumorNCT01039519Synta Pharmaceuticals Corp.27