RAD001 in Advanced Sarcoma
2013年4月11日 更新者：Jin-Hee Ahn、Asan Medical Center
A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
研究概览
详细说明
This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.
研究类型
介入性
注册 (实际的)
41
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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Daegu、大韩民国
- Yeongnam University College of Medicine
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Daejeon、大韩民国、301-721
- Chungnam National University Hospital
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Seoul、大韩民国、135-710
- Samsung Medical Center
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Seoul、大韩民国、110-744
- Seoul National University Hospital
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Seoul、大韩民国、120-752
- Yonsei Cancer Center
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Seoul、大韩民国、126-1
- Korea University
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Gyeonggi
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Seongnam、Gyeonggi、大韩民国、463-707
- Seoul National University Bundang Hospital
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N/A = Not Applicable
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Seoul、N/A = Not Applicable、大韩民国、138-736
- Asan Medical Center, University of Ulsan College of Medicine
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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
17年 及以上 (孩子、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:
- Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
- Any of above drugs is allowed to be used as adjuvant treatment.
- Unidimensionally measurable disease
- 3 or less than prior chemotherapies
- Age 17 years old or older
- ECOG performance status 2 or less, Life expectancy 6 month or less
- Adequate bone marrow, liver, kidney, and cardiac function
- Written informed consent
Exclusion Criteria:
- Pregnant or lactating patients
- Patients with resectable metastasis
- Patients with history of CNS metastasis
- Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
- Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
- Any preexisting medical condition of sufficient severity to prevent full compliance with the study
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）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：RAD001
RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
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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 |
|---|---|---|
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Progression-free survival rate at 16 weeks
大体时间：16 weeks
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Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
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16 weeks
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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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Progression-free survival
大体时间：Up to 24 months
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Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
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Up to 24 months
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Overall survival
大体时间：Up to 24 months
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Defined from the initiation of everolimus to death of any cause.
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Up to 24 months
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Response rate
大体时间：Up to 24 months
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Defined as the proportion of complete response and partial response per RECIST criteria.
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Up to 24 months
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Toxicity
大体时间：Up to 24 months
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Any adverse events occurred during the treatment with study drug.
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Up to 24 months
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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。
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。
一般刊物
- Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q, Blay JY, Frisch J, Van Glabbeke M, Hermans C, Van Oosterom A, Tursz T, Verweij J. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 2000 Jul;18(14):2676-84. doi: 10.1200/JCO.2000.18.14.2676.
- Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45. doi: 10.1200/JCO.1995.13.7.1537.
- Clark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005 Aug 18;353(7):701-11. doi: 10.1056/NEJMra041866. No abstract available.
- Edmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S, Parkinson DR. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993 Jul;11(7):1269-75. doi: 10.1200/JCO.1993.11.7.1269.
- Verweij J, Lee SM, Ruka W, Buesa J, Coleman R, van Hoessel R, Seynaeve C, di Paola ED, van Glabbeke M, Tonelli D, Judson IR. Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group. J Clin Oncol. 2000 May;18(10):2081-6. doi: 10.1200/JCO.2000.18.10.2081.
- Hartmann JT, Patel S. Recent developments in salvage chemotherapy for patients with metastatic soft tissue sarcoma. Drugs. 2005;65(2):167-78. doi: 10.2165/00003495-200565020-00002.
- van Oosterom AT, Mouridsen HT, Nielsen OS, Dombernowsky P, Krzemieniecki K, Judson I, Svancarova L, Spooner D, Hermans C, Van Glabbeke M, Verweij J; EORTC Soft Tissue and Bone Sarcoma Group. Results of randomised studies of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) with two different ifosfamide regimens in first- and second-line chemotherapy in advanced soft tissue sarcoma patients. Eur J Cancer. 2002 Dec;38(18):2397-406. doi: 10.1016/s0959-8049(02)00491-4.
- Wan X, Helman LJ. The biology behind mTOR inhibition in sarcoma. Oncologist. 2007 Aug;12(8):1007-18. doi: 10.1634/theoncologist.12-8-1007.
- Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. doi: 10.1016/S0140-6736(08)61039-9. Epub 2008 Jul 22.
- Yoo C, Lee J, Rha SY, Park KH, Kim TM, Kim YJ, Lee HJ, Lee KH, Ahn JH. Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide. Invest New Drugs. 2013 Dec;31(6):1602-8. doi: 10.1007/s10637-013-0028-7. Epub 2013 Sep 14.
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
2010年4月1日
初级完成 (实际的)
2013年1月1日
研究注册日期
首次提交
2013年4月10日
首先提交符合 QC 标准的
2013年4月11日
首次发布 (估计)
2013年4月12日
研究记录更新
最后更新发布 (估计)
2013年4月12日
上次提交的符合 QC 标准的更新
2013年4月11日
最后验证
2013年4月1日
更多信息
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