Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
2020年12月16日 更新者：Novartis Pharmaceuticals
A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist.
The study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.
研究概览
研究类型
介入性
注册 (实际的)
13
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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Aichi
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Nagoya-city、Aichi、日本、467-8602
- Novartis Investigative Site
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Hyogo
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Kobe-city、Hyogo、日本、650-0017
- Novartis Investigative Site
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Kyoto
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Kyoto-city、Kyoto、日本、602-8566
- Novartis Investigative Site
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Okayama
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Okayama-city、Okayama、日本、701-1192
- Novartis Investigative 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 relapsed and/or refractory MM for which no standard effective treatment options exist.
Exclusion Criteria:
-Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
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：不适用
- 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：LGH447
LGH447, QD
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LGH447, QD
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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 |
|---|---|---|
|
Incidence rate of dose limiting toxicities
大体时间：28 days
|
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients
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28 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of patients with adverse events as a measure of safety and tolerability of LGH447
大体时间：28 days and till the end of the study, an average of 84 days
|
Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms
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28 days and till the end of the study, an average of 84 days
|
|
Pharmacokinetics profile of LGH447 and its metabolites if appropriate
大体时间：Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1
|
PK parameters such as AUC, Cmax, Tmax, T1/2.
Cycle = 28 days
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Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1
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Overall Response Rate
大体时间：Every 28 days till the end of the study, an average of 84 days
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Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
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Every 28 days till the end of the study, an average of 84 days
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Disease control rate
大体时间：Every 28 days till the end of the study, an average of 84 days
|
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
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Every 28 days till the end of the study, an average of 84 days
|
|
Clinical benefit rate
大体时间：Every 28 days till the end of the study, an average of 84 days
|
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
|
Every 28 days till the end of the study, an average of 84 days
|
|
Duration of Response
大体时间：Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma
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Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
|
Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma
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Progression Free Survival
大体时间：Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause
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Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
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Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause
|
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Time to response
大体时间：Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response
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Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
|
Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response
|
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
2014年9月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2014年5月30日
首先提交符合 QC 标准的
2014年6月9日
首次发布 (估计)
2014年6月11日
研究记录更新
最后更新发布 (实际的)
2020年12月17日
上次提交的符合 QC 标准的更新
2020年12月16日
最后验证
2017年1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.