A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90095
- UCLA Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana Farber Cancer Institute
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health and Science University-Knight Cancer Institute
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19111-2497
- Fox Chase Cancer Center
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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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: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.
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Ganetespib 200 mg/m^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week.
Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
大体时间:Week 16 up to Week 47
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Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.
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Week 16 up to Week 47
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
大体时间:Week 16 up to Week 47
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Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.
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Week 16 up to Week 47
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Kaplan-Meier Estimate of Progression Free Survival (PFS)
大体时间:Day 1 up to Week 47
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PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as
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Day 1 up to Week 47
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Kaplan-Meier Estimate of Overall Survival
大体时间:Day 1 up to week 97
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Overall survival was defined as the time from first dose to death or the date last known alive.
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Day 1 up to week 97
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Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
大体时间:Day 2 to Day 10
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PET imaging was completed on selected patients only from one investigative site.
Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10.
PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999].
Tumor response was considered a complete response (CR) or a partial response (PR).
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Day 2 to Day 10
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Count of Participants With Treatment-Emergent Adverse Events (AEs)
大体时间:Day 1 up to Week 51
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Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. Dose modification includes dose delay and dose reduction. |
Day 1 up to Week 51
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合作者和调查者
研究记录日期
研究主要日期
学习开始
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Ganetespib的临床试验
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