A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
研究概览
简要总结
The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.
详细描述
Planned:
- Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
- Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.
Analyzed:
- Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.
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
- •Must be at least 18 years of age at the time of study entry
- •Must have histologically confirmed metastatic and/or unresectable GIST
- •Must have measurable disease on computed tomography or magnetic resonance imaging as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- •Must have documented failure (due to either progression or intolerance)of at least prior imatinib and sunitinib. Previous administration of other known heat shock protein 90 (Hsp90) inhibitors is permitted
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Must have acceptable laboratory values as defined in the protocol
排除标准
- •Known central nervous system metastases
- •Major surgery within 4 weeks prior to receiving STA-9090
- •Use of any investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter prior to receiving STA-9090
- •No treatment with chronic immunosuppressants
- •Must have otherwise adequate health status as defined in the protocol
- •Left ventricular ejection fraction (LVEF) < than or = 50% at baseline
- •Baseline corrected QT interval (QTc) > 470 msec
- •Pregnant or lactating females
研究组 & 干预措施
ganetespib 200 mg/m^2
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
干预措施: Ganetespib (Drug)
结局指标
主要结局
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
时间窗: Week 16 up to Week 47
Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions * SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions
次要结局
- Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0(Week 16 up to Week 47)
- Kaplan-Meier Estimate of Progression Free Survival (PFS)(Day 1 up to Week 47)
- Kaplan-Meier Estimate of Overall Survival(Day 1 up to week 97)
- Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)(Day 2 to Day 10)
- Count of Participants With Treatment-Emergent Adverse Events (AEs)(Day 1 up to Week 51)