Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma
2017年6月23日 更新者：GlaxoSmithKline
A Phase I Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of [GSK461364], a Polo-like Kinase 1 (PLK1) Inhibitor, in Adult Subjects With Advanced Solid Tumor or Non-Hodgkins Lymphoma
This is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with solid tumors and Non-Hodgkins lymphoma.
研究概览
研究类型
介入性
注册 (实际的)
41
阶段
- 阶段1
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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Belfast, Northern Ireland、英国、BT9 7AB
- GSK Investigational Site
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London、英国、W12 0NN
- GSK Investigational Site
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Surrey
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Sutton、Surrey、英国、SM2 5PT
- 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
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:
- Confirmed diagnosis of advanced solid tumor or Non-Hodgkins Lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory to standard therapies
- At least 18 years of age
- Female who are of non-childbearing potential or who have a negative pregnancy test who uses approved contraception
- Male with a female partner of childbearing potential must have had a vasectomy or both are using approved contraception
- Lab values that are within range as described in the protocol
- Paraffin-embedded archival tumor tissue available for testing
- Signed written informed consent
Exclusion Criteria:
- Undergone major surgery or received anti-cancer therapy
- History of hemolytic anemia
- Clinical lab tests that are out of range as described in the protocol
- Females who are pregnant or lactating
- Significant heart problems
- Serious or unstable pre-existing medical or psychiatric condition
- Are not able to comply with the study protocol
- Use of prohibited medications
- Have low blood pressure
- Evidence of symptomatic or untreated central nervous system involvement and require corticosteroids or anti-epileptic meds
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：Stage A
Stage A will identify maximum tolerated doses for either Schedule 1 - GSK461364 given once weekly on Day 1, 8 and 15 every 28 days; Schedule 2 - GSK 461364 given twice weekly Days 1, 2, 8, 9, 15 and 16; Schedule 3 Daily on Day 1 to Day 15 every 21 days.
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GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs.
The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.
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实验性的：Stage B
Evaluate safety, PK, pharmacodynamic (PD) & tumor response in expanded cohorts at the MTD for at least one schedule from Stage A.
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GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs.
The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Plasma levels for GSK461364 will be taken at:Schedule 1:Day 1, 8, 15, & 22 for Cycle 1 and Day 1, 8 & 15 for subsequent cycles.Schedule 2:Day 1, 2, 8, 9, 15, & 16 for all cycles.Schedule 3:Day 1 to 5 for all cycles.
大体时间：16 Days
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16 Days
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次要结果测量
结果测量 |
大体时间 |
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Safety will be evaluated by: - Physical exam at screen & then D1 for each cycle - 12 lead ECG & telemetry at screen & Wk 1 to 3 for Schedule 1 & 2, & Wk 1 & 2 (ECG only) for Schedule 3. - Lab tests & AE monitoring throughout the study.
大体时间：16 Days
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16 Days
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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。
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 (实际的)
2007年8月16日
初级完成 (实际的)
2009年9月29日
研究完成 (实际的)
2009年9月29日
研究注册日期
首次提交
2007年9月27日
首先提交符合 QC 标准的
2007年9月27日
首次发布 (估计)
2007年9月28日
研究记录更新
最后更新发布 (实际的)
2017年6月26日
上次提交的符合 QC 标准的更新
2017年6月23日
最后验证
2017年6月1日
更多信息
与本研究相关的术语
其他研究编号
- PLK107427
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
研究数据/文件
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临床研究报告
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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知情同意书
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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数据集规范
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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统计分析计划
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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带注释的病例报告表
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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个人参与者数据集
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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研究协议
信息标识符：PLK107427信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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.