A Study In Patients With Advanced Solid Tumor
2012年5月17日 更新者：Pfizer
A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
研究概览
研究类型
介入性
注册 (实际的)
6
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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Hyogo-ken
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Kobe-shi、Hyogo-ken、日本
- Pfizer 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
20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:
- Patients histologically or cytologically diagnosed with advanced solid tumors
- Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
- Patients with no uncontrolled hypertension
Exclusion Criteria:
- Patients who have central lung lesions involving major blood vessels
- Patients who require anticoagulant therapy.
- Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
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：阿昔替尼
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Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient.
After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.
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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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Single Dose: Maximum Observed Plasma Concentration (Cmax)
大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)
大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
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Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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Single Dose: Plasma Decay Half-Life (t1/2)
大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
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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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Multiple Dose: Maximum Observed Plasma Concentration (Cmax)
大体时间：Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Cmax at multiple dosing
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Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
大体时间：Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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The dosing interval was 12 hours in this study.
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Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Tmax at multiple dosing
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Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)
大体时间：Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)
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Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose
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Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )
大体时间：Prior to the initial dose (baseline) and Day 1 of Cycle 2
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Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF
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Prior to the initial dose (baseline) and Day 1 of Cycle 2
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Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)
大体时间：Up to 470 days
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CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions.
PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions.
CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks.
PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.
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Up to 470 days
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Number of Participants With Adverse Events
大体时间：Up to 470 days of treatment plus 28-days follow-up
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Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.
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Up to 470 days of treatment plus 28-days follow-up
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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
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
2008年7月1日
初级完成 (实际的)
2010年4月1日
研究完成 (实际的)
2010年4月1日
研究注册日期
首次提交
2008年7月30日
首先提交符合 QC 标准的
2008年7月30日
首次发布 (估计)
2008年8月1日
研究记录更新
最后更新发布 (估计)
2012年5月23日
上次提交的符合 QC 标准的更新
2012年5月17日
最后验证
2012年5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.
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