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

2021년 1월 17일 업데이트: 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).

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (실제)

162

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대만
      • Kaohsiung, 대만
        • Research Site
      • Taichung, 대만
        • Research Site
      • Tainan, 대만
        • Research Site
      • Tainan, 대만
        • Research Site 2
      • Taipei, 대만
        • Research Site
      • Taipei, 대만
        • Research Site 2
  • 대한민국
      • Cheongju-si, 대한민국
        • Research Site
      • Goyang-si, 대한민국
        • Research Site
      • Hwasun, 대한민국
        • Research Site
      • Incheon, 대한민국
        • Research Site
      • Seongnam-si, 대한민국
        • Research Site 2
      • Seongnam-si, 대한민국
        • Research Site
      • Seoul, 대한민국
        • Research Site
      • Seoul, 대한민국
        • Research Site 2
      • Seoul, 대한민국
        • Research Site 3
      • Seoul, 대한민국
        • Research Site 4
      • Seoul, 대한민국
        • Research Site 5
      • Seoul, 대한민국
        • Research Site 6
      • Seoul, 대한민국
        • Research Site 7
      • Seoul, 대한민국
        • Research Site 8
  • 독일
      • Berlin, 독일
        • Research Site
      • Homburg, 독일
        • Research Site
      • Leipzig, 독일
        • Research Site
      • München, 독일
        • Research Site
      • Ulm, 독일
        • Research Site
  • 말레이시아
      • Kuala Lumpur, 말레이시아
        • Research Site
      • Kuantan, 말레이시아
        • Research Site
      • Kuching, 말레이시아
        • Research Site
    • Penang
      • George Town, Penang, 말레이시아
        • Research Site
  • 미국
    • California
      • Beverly Hills, California, 미국
        • Research Site
      • Burbank, California, 미국
        • Research Site
      • Los Angeles, California, 미국
        • Research Site
      • Los Angeles, California, 미국
        • Research Site 2
      • Montebello, California, 미국
        • Research Site
      • Orange, California, 미국
        • Research Site
      • San Diego, California, 미국
        • Research Site
    • Florida
      • Boca Raton, Florida, 미국
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, 미국
        • Research Site
    • Illinois
      • Evanston, Illinois, 미국
        • Research Site
    • Maryland
      • Bethesda, Maryland, 미국
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, 미국
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, 미국
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, 미국
        • Research Site
    • Washington
      • Washington, Washington, 미국
        • Research Site
  • 스페인
      • Barcelona, 스페인
        • Research Site
      • Barcelona, 스페인
        • Research Site 2
      • Barcelona, 스페인
        • Research Site 3
      • Barcelona, 스페인
        • Research Site 4
      • La Coruna, 스페인
        • Research Site
      • Madrid, 스페인
        • Research Site
      • Madrid, 스페인
        • Research Site 2
      • Navarra, 스페인
        • Research Site
      • San Sebastian, 스페인
        • Research Site
      • Valencia, 스페인
        • Research Site
      • Valencia, 스페인
        • Research Site 2
  • 이탈리아
      • Bergamo, 이탈리아
        • Research Site
      • Bologna, 이탈리아
        • Research Site
      • Catania, 이탈리아
        • Research Site
      • Milano, 이탈리아
        • Research Site
      • Rome, 이탈리아
        • Research Site
  • 캐나다
      • Toronto, 캐나다
        • Research Site
  • 필리핀 제도
      • Cebu, 필리핀 제도
        • Research Site
    • Kalakhang Maynila
      • Makati, Kalakhang Maynila, 필리핀 제도
        • Research Site
    • Manila
      • Pasig, Manila, 필리핀 제도
        • Research Site
    • Metro Manila
      • Manila, Metro Manila, 필리핀 제도
        • Research Site 2
      • Manila, Metro Manila, 필리핀 제도
        • Research Site
  • 호주
      • Darlinghurst, 호주
        • Research Site
      • Fitzroy, 호주
        • Research Site
      • Frankston, 호주
        • Research Site
      • Kogarah, 호주
        • Research Site
      • St Albans, 호주
        • Research Site
      • Woolloongabba, 호주
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
의약품: 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.
다른 이름들:
  • 올무티닙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective response rate (ORR)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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).
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hanmi Pharmaceutical Company Limited

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 8월 31일

기본 완료 (실제)

2020년 12월 8일

연구 완료 (실제)

2020년 12월 8일

연구 등록 날짜

최초 제출

2015년 6월 22일

QC 기준을 충족하는 최초 제출

2015년 6월 25일

처음 게시됨 (추정)

2015년 6월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 1월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 1월 17일

마지막으로 확인됨

2021년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

비소세포폐암에 대한 임상 시험

HM61713에 대한 임상 시험

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