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Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

2021年1月17日 更新者：Hanmi Pharmaceutical Company Limited

A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

研究概览

地位

终止

条件

干预/治疗

详细说明

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

研究类型

介入性

注册 (实际的)

162

阶段

  • 阶段2

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

  • 加拿大
      • Toronto、加拿大
        • Research Site
  • 台湾
      • Kaohsiung、台湾
        • Research Site
      • Taichung、台湾
        • Research Site
      • Tainan、台湾
        • Research Site
      • Tainan、台湾
        • Research Site 2
      • Taipei、台湾
        • Research Site
      • Taipei、台湾
        • Research Site 2
  • 大韩民国
      • Cheongju-si、大韩民国
        • Research Site
      • Goyang-si、大韩民国
        • Research Site
      • Hwasun、大韩民国
        • Research Site
      • Incheon、大韩民国
        • Research Site
      • Seongnam-si、大韩民国
        • Research Site 2
      • Seongnam-si、大韩民国
        • Research Site
      • Seoul、大韩民国
        • Research Site
      • Seoul、大韩民国
        • Research Site 2
      • Seoul、大韩民国
        • Research Site 3
      • Seoul、大韩民国
        • Research Site 4
      • Seoul、大韩民国
        • Research Site 5
      • Seoul、大韩民国
        • Research Site 6
      • Seoul、大韩民国
        • Research Site 7
      • Seoul、大韩民国
        • Research Site 8
  • 德国
      • Berlin、德国
        • Research Site
      • Homburg、德国
        • Research Site
      • Leipzig、德国
        • Research Site
      • München、德国
        • Research Site
      • Ulm、德国
        • Research Site
  • 意大利
      • Bergamo、意大利
        • Research Site
      • Bologna、意大利
        • Research Site
      • Catania、意大利
        • Research Site
      • Milano、意大利
        • Research Site
      • Rome、意大利
        • Research Site
  • 澳大利亚
      • Darlinghurst、澳大利亚
        • Research Site
      • Fitzroy、澳大利亚
        • Research Site
      • Frankston、澳大利亚
        • Research Site
      • Kogarah、澳大利亚
        • Research Site
      • St Albans、澳大利亚
        • Research Site
      • Woolloongabba、澳大利亚
        • Research Site
  • 美国
    • California
      • Beverly Hills、California、美国
        • Research Site
      • Burbank、California、美国
        • Research Site
      • Los Angeles、California、美国
        • Research Site
      • Los Angeles、California、美国
        • Research Site 2
      • Montebello、California、美国
        • Research Site
      • Orange、California、美国
        • Research Site
      • San Diego、California、美国
        • Research Site
    • Florida
      • Boca Raton、Florida、美国
        • Research Site
    • Hawaii
      • Honolulu、Hawaii、美国
        • Research Site
    • Illinois
      • Evanston、Illinois、美国
        • Research Site
    • Maryland
      • Bethesda、Maryland、美国
        • Research Site
    • Massachusetts
      • Boston、Massachusetts、美国
        • Research Site
    • New Hampshire
      • Lebanon、New Hampshire、美国
        • Research Site
    • North Carolina
      • Charlotte、North Carolina、美国
        • Research Site
    • Washington
      • Washington、Washington、美国
        • Research Site
  • 菲律宾
      • Cebu、菲律宾
        • Research Site
    • Kalakhang Maynila
      • Makati、Kalakhang Maynila、菲律宾
        • Research Site
    • Manila
      • Pasig、Manila、菲律宾
        • Research Site
    • Metro Manila
      • Manila、Metro Manila、菲律宾
        • Research Site 2
      • Manila、Metro Manila、菲律宾
        • Research Site
  • 西班牙
      • Barcelona、西班牙
        • Research Site
      • Barcelona、西班牙
        • Research Site 2
      • Barcelona、西班牙
        • Research Site 3
      • Barcelona、西班牙
        • Research Site 4
      • La Coruna、西班牙
        • Research Site
      • Madrid、西班牙
        • Research Site
      • Madrid、西班牙
        • Research Site 2
      • Navarra、西班牙
        • Research Site
      • San Sebastian、西班牙
        • Research Site
      • Valencia、西班牙
        • Research Site
      • Valencia、西班牙
        • Research Site 2
  • 马来西亚
      • Kuala Lumpur、马来西亚
        • Research Site
      • Kuantan、马来西亚
        • Research Site
      • Kuching、马来西亚
        • Research Site
    • Penang
      • George Town、Penang、马来西亚
        • Research Site

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:

  • Age: at least 20 years of age
  • Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
  • Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
  • At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
  • World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
  • Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
  • At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
  • Adequate hematological and biological function
  • Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
  • Male patients should be documented to be sterile or agree to use barrier contraception
  • Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia

Exclusion Criteria:

  • Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
  • Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
  • Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
  • Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
  • History of any other malignancy
  • Clinically significant uncontrolled condition(s)
  • Active or chronic pancreatitis
  • Anyone with cardiac abnormalities or history
  • Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
  • Pregnant or breast feeding
  • In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

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
实验性的：HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
药品：HM61713
800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.
其他名称：
  • 奥穆替尼

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
Objective response rate (ORR)
大体时间：At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1
大体时间：At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess clinical efficacy of HM61713 regarding disease control rate (DCR).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death
大体时间：At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first
大体时间：At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Overall survival (OS), defined as the time from first administration of study drug until death from any cause
大体时间：From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
To assess clinical efficacy of HM61713 regarding Overall survival (OS).
From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1
大体时间：At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess clinical efficacy of HM61713 regarding Time to progression (TTP).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response
大体时间：At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess clinical efficacy of HM61713 regarding tumor shrinkage.
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Peak concentration (Cmax) of HM61713
大体时间：Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
To determine the pharmacokinetic (PK) profile of HM61713.
Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Trough plasma concentration (Ctrough) of HM61713
大体时间：Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
To determine the pharmacokinetic (PK) profile of HM61713.
Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713
大体时间：Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
To determine the pharmacokinetic (PK) profile of HM61713.
Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Patient reported outcomes (PROs)
大体时间：At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.
At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
ECG/QTc (absolute values and change from baseline)
大体时间：Adverse events will be collected from baseline until 28 days after the last dose
To evaluate the effect of HM61713 on the QT interval.
Adverse events will be collected from baseline until 28 days after the last dose
Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
大体时间：Adverse events will be collected from baseline until 28 days after the last dose
To assess the safety and tolerability of HM61713.
Adverse events will be collected from baseline until 28 days after the last dose
QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS.
大体时间：Adverse events will be collected from baseline until 28 days after the last dose
To assess the safety and tolerability of HM61713.
Adverse events will be collected from baseline until 28 days after the last dose

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

Hanmi Pharmaceutical Company Limited

调查人员

  • 首席研究员：Keunchil Park, M.D., Ph.D、Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
  • 首席研究员：Pasi A. Jänne, M.D., Ph.D、Dana-Farber Cancer Institute, Boston, MA, USA

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)

2015年8月31日

初级完成 (实际的)

2020年12月8日

研究完成 (实际的)

2020年12月8日

研究注册日期

首次提交

2015年6月22日

首先提交符合 QC 标准的

2015年6月25日

首次发布 (估计)

2015年6月30日

研究记录更新

最后更新发布 (实际的)

2021年1月22日

上次提交的符合 QC 标准的更新

2021年1月17日

最后验证

2021年1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

  • HM-EMSI-202
  • 2015-001435-21 (EudraCT编号)

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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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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