The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
2012年6月11日 更新者:AstraZeneca
An Open-Label, Phase II Study to Evaluate the Biological Activity of Cediranib (AZD2171) as Measured by [F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET) Response, in Patients With Metastatic Gastro-Intestinal Stromal Tumours (GIST) Resistant or Intolerant to Imatinib Mesylate
To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard therapy.
研究概览
研究类型
介入性
注册 (实际的)
35
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Manchester、英国
- Research Site
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Sutton、英国
- Research Site
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histological or cytological confirmation of GIST which is resistant or intolerant to imatinib mesylate, or metastatic STS, which is refractory to standard therapies or for which no standard therapy exists
Exclusion Criteria:
- Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes.
- Patients with a history of poorly controlled high blood pressure
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
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 |
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Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.
大体时间:Baseline and 8 days after dosing.
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[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET).
Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours.
SUVmax at Day 8 minus SUVmax at Baseline.
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Baseline and 8 days after dosing.
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Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.
大体时间:FDG-PET assessment at Baseline and 29 days after dosing.
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SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients
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FDG-PET assessment at Baseline and 29 days after dosing.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Objective Tumour Response, Investigator Review
大体时间:RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.
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Number of patients with complete (CR) /partial response (PR) (based on RECIST) as assessed by the Investigator.
CR is defined as Disappearance of all target lesions.
PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.
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RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.
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-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.
大体时间:CT assessments at Baseline and Week 8
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Central review of CT images taking the longest diameter measured in millimetres at week 8 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.
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CT assessments at Baseline and Week 8
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Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.
大体时间:CT assessments at Baseline and Week 16.
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Central review of CT images taking the longest diameter measured in millimetres at week 16 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.
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CT assessments at Baseline and Week 16.
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Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.
大体时间:CT assessments at Baseline and Week 8
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Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline.
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CT assessments at Baseline and Week 8
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Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.
大体时间:CT assessments at Baseline and Week 16
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Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.
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CT assessments at Baseline and Week 16
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Jane Robertson, MD、AstraZeneca
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年9月1日
初级完成 (实际的)
2008年6月1日
研究完成 (实际的)
2009年12月1日
研究注册日期
首次提交
2006年10月5日
首先提交符合 QC 标准的
2006年10月5日
首次发布 (估计)
2006年10月6日
研究记录更新
最后更新发布 (估计)
2012年7月16日
上次提交的符合 QC 标准的更新
2012年6月11日
最后验证
2012年6月1日
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.
AZD2171的临床试验
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The Christie NHS Foundation TrustAstraZeneca; Cancer Research UK终止
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National Cancer Institute (NCI)完全的复发性儿童髓母细胞瘤 | 复发性儿童室管膜瘤 | 儿童非典型畸胎瘤样/横纹肌样瘤 | 儿童 I 级脑膜瘤 | 儿童 II 级脑膜瘤 | 儿童 III 级脑膜瘤 | 儿童幕下室管膜瘤 | 儿童幕上室管膜瘤 | 复发性儿童脑干胶质瘤 | 复发性儿童小脑星形细胞瘤 | 复发性儿童脑星形细胞瘤 | 复发性儿童松果体母细胞瘤 | 复发性儿童室管膜下巨细胞星形细胞瘤 | 复发性儿童幕上原始神经外胚层肿瘤 | 复发性儿童视觉通路神经胶质瘤 | 儿童中枢神经系统生殖细胞肿瘤 | 儿童脊髓肿瘤 | 儿童少突神经胶质瘤 | 儿童脑间变性星形细胞瘤 | 复发性儿童脑肿瘤 | 儿童脑星形细胞瘤美国
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National Cancer Institute (NCI)终止
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National Cancer Institute (NCI)完全的复发性下咽鳞状细胞癌 | 复发性喉鳞状细胞癌 | 复发性口咽鳞状细胞癌 | 唾液腺鳞状细胞癌 | 复发性唇和口腔鳞状细胞癌 | 复发性鼻咽角化鳞状细胞癌 | 复发性喉疣状癌 | 原发隐匿的颈部复发性转移性鳞状细胞癌 | 复发性鼻腔和鼻窦鳞状细胞癌 | 复发性口腔疣状癌 | 复发性唾液腺癌 | 原发隐匿的颈部转移性鳞状细胞癌 | 舌癌 | IV 期下咽鳞状细胞癌 | IV 期喉鳞状细胞癌 | IV 期唇和口腔鳞状细胞癌 | IV 期口咽鳞状细胞癌 | IV 期鼻咽角化鳞状细胞癌 | IV 期大唾液腺癌 | IV 期喉疣状癌 | IV 期鼻腔和鼻窦鳞状细胞癌 | IV 期口腔疣状癌 | 未经治疗的转移性鳞状细胞癌至颈部并伴有隐匿性原发灶美国
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National Cancer Institute (NCI)NRG Oncology完全的
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National Cancer Institute (NCI)完全的
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Peter MacCallum Cancer Centre, Australia招聘中