Study Evaluating HKI-272 in Tumors
2018年8月17日 更新者：Puma Biotechnology, Inc.
An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272.
In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.
研究概览
研究类型
介入性
注册 (实际的)
73
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
-
-
Florida
-
Tampa、Florida、美国、33612
- H. Lee Moffitt Cancer Center & Research Institute
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
-
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Missouri
-
Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
-
-
Ohio
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Cleveland、Ohio、美国、44195
- The Cleveland Clinic Foundation Taussig Cancer Center
-
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Tennessee
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Nashville、Tennessee、美国、37203
- The Sarah Cannon Cancer Center
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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:
- Her2/neu or Her1/EGFR positive cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion Criteria:
- Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m^2
- Patients with significant cardiac risk factors
- Active central nervous system metastasis
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：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：来那替尼 80 毫克
|
HKI-272
|
|
实验性的：来那替尼 240 毫克
|
HKI-272
|
|
实验性的：来那替尼 320 毫克
|
HKI-272
|
|
实验性的：Neratinib 40 mg
|
HKI-272
|
|
实验性的：Neratinib 120 mg
|
HKI-272
|
|
实验性的：Neratinib 180 mg
|
HKI-272
|
|
实验性的：Neratinib 400 mg
|
HKI-272
|
|
实验性的：Neratinib 320 mg MTD
|
HKI-272
|
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 |
|---|---|---|
|
Dose Limiting Toxicity (DLT)
大体时间：From first dose date to day 14
|
DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0.
DLTs were assessed from the first single dose to 14 days of continuous daily administration.
|
From first dose date to day 14
|
|
Maximum Tolerated Dose (MTD)
大体时间：From first dose date to day 14
|
If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.
|
From first dose date to day 14
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Best Overall Response
大体时间：From first dose date to progression or last tumor assessment, up to 39 weeks.
|
Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), >=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start.
The best overall response was the best response recorded from start of treatment until PD/recurrence.
In general, the subject's best response assignment depended on achievement of both measurement and confirmation criteria.
|
From first dose date to progression or last tumor assessment, up to 39 weeks.
|
|
Duration of Response
大体时间：From start date of response to first PD, up to 39 weeks.
|
Duration of response of responders (PR+) by Kaplan-Meier estimate
|
From start date of response to first PD, up to 39 weeks.
|
|
Progression Free Survival
大体时间：From first dose date to progression or death, up to 39 weeks.
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
From first dose date to progression or death, up to 39 weeks.
|
|
Objective Response Rate
大体时间：From first dose date to progression/death or last assessment, up to 39 weeks
|
Patients with PR or higher responses, evaluable population
|
From first dose date to progression/death or last assessment, up to 39 weeks
|
|
Clinical Benefit Rate
大体时间：From first dose date to progression/death or last assessment, up to 39 weeks.
|
Patients with PR or higher responses or SD>=24 weeks, evaluable population
|
From first dose date to progression/death or last assessment, up to 39 weeks.
|
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。
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)
2003年11月1日
初级完成 (实际的)
2007年1月1日
研究完成 (实际的)
2007年1月1日
研究注册日期
首次提交
2005年9月2日
首先提交符合 QC 标准的
2005年9月2日
首次发布 (估计)
2005年9月5日
研究记录更新
最后更新发布 (实际的)
2018年9月17日
上次提交的符合 QC 标准的更新
2018年8月17日
最后验证
2018年8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.