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Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

2018年8月27日 更新者：Eisai Co., Ltd.

Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

66

阶段

  • 阶段2
  • 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

  • 大韩民国
    • Seoul
      • Gangnam-gu、Seoul、大韩民国
      • Songpa-gu、Seoul、大韩民国
  • 日本
    • Chiba
      • Kashiwa-shi、Chiba、日本
    • Fukuoka
      • Kurume-shi、Fukuoka、日本
    • Hokkaido
      • Sapporo-shi、Hokkaido、日本
    • Kanagawa
      • Kawasaki-shi、Kanagawa、日本
    • Osaka
      • Osaka-shi、Osaka、日本
      • Osakasayama-shi、Osaka、日本
    • Saga
      • Saga-shi、Saga、日本
    • Tokyo
      • Chuo-ku、Tokyo、日本
      • Minato-ku、Tokyo、日本
      • Musashino-shi、Tokyo、日本

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 至 80年 (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:

  1. Histologically or clinically confirmed diagnosis of advanced HCC.
  2. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
  3. Adequate laboratory values/organ function tests.

Exclusion criteria:

  1. Simultaneous or metachronous cancers.
  2. Pericardial, ascites, or pleural effusion requiring drainage.
  3. Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
  4. Malabsorption syndrome.
  5. Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
  6. Use of drugs known to inhibit cytochrome P3A4.

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
实验性的：乐伐替尼
药品：Lenvatinib
In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.
其他名称：
  • E7080

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
Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib
大体时间：Up to 28 days (Cycle1)
The MTD was defined as the highest dose level at which no more than 1 of 6 participants had a dose limiting toxicities (DLT). DLT was defined as any of the following events: grade 4 or higher hematologic toxicity or grade 3 thrombocytopenia that required blood transfusion, grade 3 or higher nonhematologic toxicity, grade 4 hypertension uncontrolled by antihypertensive drug(s), aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than (>) 10.0*upper limit of normal (ULN), proteinuria 4+ by urine dipstick, proteinuria 3+ by urine dipstick was to be monitored by 24-hour urine collection, proteinuria >3.5 gram (g) for 24 hours, diarrhea/vomiting/nausea of grade 3 or higher that was uncontrollable despite maximal supportive therapies and abnormal clinical laboratory values that required no treatment, grade 3 proteinuria by dipstick, diarrhea/vomiting/nausea that was managed with supportive therapies were not considered as DLT.
Up to 28 days (Cycle1)
Phase 2: Time to Progression (TTP) by Independent Review Assessment
大体时间：From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)
TTP was defined as the time from the date of registration to the date when progressive disease (PD) was first confirmed. PD was evaluated according to modified response evaluation criteria in solid tumors (mRECIST) by an independent imaging review. PD was defined as at least a 20 percent (%) increase in the sum of long diameter (LD) of target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 millimeter (mm) (including new lesions).
From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)

次要结果测量

结果测量
措施说明
大体时间
Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment
大体时间：Every 8 weeks (approximately up to 18.4 months)
BOR was performed using RECIST1.1 and was measured as complete response (CR) defined as when an overall response of CR was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of CR was confirmed and the BOR established as CR was regarded as the "CR confirmed date), partial response (PR) defined as when the overall response of PR or better (CR or PR) was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of PR was confirmed and the BOR established as PR will be regarded as the "PR confirmed date), PD defined as when the BOR was neither CR, PR, or stable disease (SD), and the overall response was PD, SD defined as when the BOR obtained was neither CR nor PR, but no PD from the initial administration to the end of Cycle 2 and the overall response of SD or better occurred at least once and not evaluable (NE) was when the overall response was NE in all cases.
Every 8 weeks (approximately up to 18.4 months)
Phase 1: Objective Response Rate (ORR) by Investigator Assessment
大体时间：From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
ORR was defined as the percentage of participants who achieved a tumor response measured by RECIST 1.1 of CR defined as disappearance of all target lesions (a short diameter is less than (<)10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
Phase 1: Disease Control Rate (DCR) by Investigator Assessment
大体时间：Up to Week 16
DCR was measured by RECIST 1.1 and defined as CR which was defined as disappearance of all target lesions (a short diameter was <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.
Up to Week 16
Phase 2: Progression-free Survival (PFS) by Independent Review Assessment
大体时间：From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
PFS was defined as the time from the date of registration until the date when PD was first confirmed or death (whichever occurred first) as determined by mRECIST and PD was defined as at least a 20% increase in the sum of long diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
Phase 2: Objective Response Rate (ORR) by Independent Review Assessment
大体时间：From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
ORR was defined as the percentage of participants who achieved a tumor response measured by mRECIST of CR defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
Phase 2: Disease Control Rate (DCR) by Independent Review Assessment
大体时间：Weeks 8 and 16
DCR was measured by mRECIST and defined as CR which was defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.
Weeks 8 and 16
Phase 2: Overall Survival (OS)
大体时间：From day of registration to the day of death (approximately 6.1 years)
OS was defined as the time from the date of registration until the date of death.
From day of registration to the day of death (approximately 6.1 years)

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

Eisai Co., Ltd.

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

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)

2009年7月24日

初级完成 (实际的)

2014年6月15日

研究完成 (实际的)

2015年8月13日

研究注册日期

首次提交

2009年7月23日

首先提交符合 QC 标准的

2009年7月23日

首次发布 (估计)

2009年7月24日

研究记录更新

最后更新发布 (实际的)

2019年2月1日

上次提交的符合 QC 标准的更新

2018年8月27日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • E7080-J081-202

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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