Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma
2016年1月4日 更新者:GlaxoSmithKline
Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma
The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.
研究概览
研究类型
介入性
注册 (实际的)
148
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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Budapest、匈牙利、01135
- GSK Investigational Site
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Bruxelles、比利时、1000
- GSK Investigational Site
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Leuven、比利时、3000
- GSK Investigational Site
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Lyon cedex 03、法国、69437
- GSK Investigational Site
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Marseille、法国、13385
- GSK Investigational Site
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Paris Cedex 05、法国、75248
- GSK Investigational Site
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Villejuif、法国、94805
- GSK Investigational Site
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Glasgow、英国、G11 6NT
- GSK Investigational Site
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Leeds、英国、LS9 7TF
- GSK Investigational Site
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London、英国、SW3 6JJ
- GSK Investigational Site
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Newcastle upon Tyne、英国、NE7 7DN
- GSK Investigational Site
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Sheffield、英国、S10 2SJ
- GSK Investigational Site
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Lancashire
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Manchester、Lancashire、英国、M20 4BX
- GSK Investigational Site
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Groningen、荷兰、9713 GZ
- GSK Investigational Site
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Leiden、荷兰、2300 RC
- GSK Investigational Site
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Rotterdam、荷兰、3075 EA
- GSK Investigational 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
21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 evidence of high or intermediate grade malignant soft tissue sarcoma, or cytological evidence in case of presence of multiple metastases. List of eligible and ineligible tumours are included in the protocol.
- Formalin fixed paraffin embedded tumour blocks and representative H/E (haematoxylin/eosin) slides must be available for histological central review. Histological central review is not required before treatment start but is mandatory within 3 months of registration. Local histopathological diagnosis will be accepted for entry into the study.
- Presence of measurable disease (according to RECIST criteria).
- Relapsed or refractory disease incurable by surgery or radiotherapy.
- Evidence of objective progression within the last 6 months (RECIST) documented by measurements of disease,
- Patients must either not be eligible for chemotherapy (for instance because of age, or because of a biological condition, or because of patient-refusal) or must have received no more than one combination or two single agents chemotherapy regimen for advanced disease; (neo) adjuvant therapy is not counted towards this requirement.
- At least 18 years of age
- WHO performance status 0 or 1
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- PT / PTT less than 1.2 x UNL.
- LVEF above the lower limit of normal for the institution, based on ECHO or MUGA
- Able to swallow and retain oral medication
- Women should not be of childbearing potential and agree to use contraceptive methods (Oral contraceptives are not allowed).
- Absence of any serious and/or unstable pre-existing medical, psychiatric or other condition (including lab abnormality) that could interfere with patient safety or obtaining informed consent.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- Written informed consent is given according to ICH/GCP, and national/local regulations before patient registration/randomization.
Exclusion Criteria:
- history of leptomeningeal or brain metastases
- history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or the patient has been free of any other malignancies for greater than 3 years).
- Class II, III or IV heart failure (NYHA classification). A patient who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible.
- Arterial or venous thrombosis, myocardial infarction, unstable angina, cardiac angioplasty or stenting within the last 3 months
- Uncontrolled or poorly controlled hypertension. Initiation or adjustment of BP medications is permitted prior to study entry, provided that patient has 3 consecutive BP readings less than 150 / 90 mm Hg each separated by a minimum of 24 hrs. These readings need to be collected prior to registration in the study.
- Women of childbearing potential, who are pregnant (negative serum pregnancy test at entry) or lactating.
- Therapeutic dose warfarin. Low molecular weight heparin and prophylactic low dose warfarin are permitted. PT/INR and PPT must meet the above inclusion criteria.
- Concurrent therapy with any specifically prohibited medication or requirement for using any of these medications during treatment with pazopanib
- Major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy, immunotherapy or other investigational agent within the last 28 days and/or not recovered from prior therapy within the last 28 days. Use of erythropoietin is considered supportive care and is permitted. The patient should have recovered from prior surgery and have no open wounds.
- History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs. No unresolved bowel obstruction or diarrhea.
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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Progression Free Survival at Week 12
大体时间:Week 12
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Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0).
Clinical progression is progression of disease without documented radiological evidence.
Progressive disease (PD), a >=20% increase in target lesions.
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Week 12
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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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Overall Survival
大体时间:Start of therapy until death (up to approximately 5 years)
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Overall survival is defined as the time from start of therapy until death.
Participants who were still alive at the time of analysis were censored.
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Start of therapy until death (up to approximately 5 years)
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Progression Free Survival
大体时间:Start of therapy until progression (up to approximately 5 years)
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Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause.
Assessments of progression were made by the investigator.
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Start of therapy until progression (up to approximately 5 years)
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Overall Response
大体时间:Baseline until either response or progression (up to approximately 5 years)
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Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study.
Progressive disease (PD), a >=20% increase in target lesions.
Clinical progression is progression of disease without documented radiological evidence.
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Baseline until either response or progression (up to approximately 5 years)
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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
- Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schoffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.
- Kasper B, Sleijfer S, Litiere S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.
- Sleijfer S, Gorlia T, Lamers C, Burger H, Blay JY, Le Cesne A, Scurr M, Collin F, Pandite L, Marreaud S, Hohenberger P. Cytokine and angiogenic factors associated with efficacy and toxicity of pazopanib in advanced soft-tissue sarcoma: an EORTC-STBSG study. Br J Cancer. 2012 Aug 7;107(4):639-45. doi: 10.1038/bjc.2012.328. Epub 2012 Jul 17.
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
2005年11月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2006年2月24日
首先提交符合 QC 标准的
2006年2月24日
首次发布 (估计)
2006年2月28日
研究记录更新
最后更新发布 (估计)
2016年2月3日
上次提交的符合 QC 标准的更新
2016年1月4日
最后验证
2015年12月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- VEG20002
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.