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

17. januar 2021 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

162

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Darlinghurst, Australien
        • Research Site
      • Fitzroy, Australien
        • Research Site
      • Frankston, Australien
        • Research Site
      • Kogarah, Australien
        • Research Site
      • St Albans, Australien
        • Research Site
      • Woolloongabba, Australien
        • Research Site
  • Canada
      • Toronto, Canada
        • Research Site
  • Filippinerne
      • Cebu, Filippinerne
        • Research Site
    • Kalakhang Maynila
      • Makati, Kalakhang Maynila, Filippinerne
        • Research Site
    • Manila
      • Pasig, Manila, Filippinerne
        • Research Site
    • Metro Manila
      • Manila, Metro Manila, Filippinerne
        • Research Site 2
      • Manila, Metro Manila, Filippinerne
        • Research Site
  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater
        • Research Site
      • Burbank, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site 2
      • Montebello, California, Forenede Stater
        • Research Site
      • Orange, California, Forenede Stater
        • Research Site
      • San Diego, California, Forenede Stater
        • Research Site
    • Florida
      • Boca Raton, Florida, Forenede Stater
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater
        • Research Site
    • Illinois
      • Evanston, Illinois, Forenede Stater
        • Research Site
    • Maryland
      • Bethesda, Maryland, Forenede Stater
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • Research Site
    • Washington
      • Washington, Washington, Forenede Stater
        • Research Site
  • Italien
      • Bergamo, Italien
        • Research Site
      • Bologna, Italien
        • Research Site
      • Catania, Italien
        • Research Site
      • Milano, Italien
        • Research Site
      • Rome, Italien
        • Research Site
  • Korea, Republikken
      • Cheongju-si, Korea, Republikken
        • Research Site
      • Goyang-si, Korea, Republikken
        • Research Site
      • Hwasun, Korea, Republikken
        • Research Site
      • Incheon, Korea, Republikken
        • Research Site
      • Seongnam-si, Korea, Republikken
        • Research Site 2
      • Seongnam-si, Korea, Republikken
        • Research Site
      • Seoul, Korea, Republikken
        • Research Site
      • Seoul, Korea, Republikken
        • Research Site 2
      • Seoul, Korea, Republikken
        • Research Site 3
      • Seoul, Korea, Republikken
        • Research Site 4
      • Seoul, Korea, Republikken
        • Research Site 5
      • Seoul, Korea, Republikken
        • Research Site 6
      • Seoul, Korea, Republikken
        • Research Site 7
      • Seoul, Korea, Republikken
        • Research Site 8
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Kuantan, Malaysia
        • Research Site
      • Kuching, Malaysia
        • Research Site
    • Penang
      • George Town, Penang, Malaysia
        • Research Site
  • Spanien
      • Barcelona, Spanien
        • Research Site
      • Barcelona, Spanien
        • Research Site 2
      • Barcelona, Spanien
        • Research Site 3
      • Barcelona, Spanien
        • Research Site 4
      • La Coruna, Spanien
        • Research Site
      • Madrid, Spanien
        • Research Site
      • Madrid, Spanien
        • Research Site 2
      • Navarra, Spanien
        • Research Site
      • San Sebastian, Spanien
        • Research Site
      • Valencia, Spanien
        • Research Site
      • Valencia, Spanien
        • Research Site 2
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site 2
      • Taipei, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site 2
  • Tyskland
      • Berlin, Tyskland
        • Research Site
      • Homburg, Tyskland
        • Research Site
      • Leipzig, Tyskland
        • Research Site
      • München, Tyskland
        • Research Site
      • Ulm, Tyskland
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
Medicin: 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.
Andre navne:
  • Olmutinib

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hanmi Pharmaceutical Company Limited

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. august 2015

Primær færdiggørelse (Faktiske)

8. december 2020

Studieafslutning (Faktiske)

8. december 2020

Datoer for studieregistrering

Først indsendt

22. juni 2015

Først indsendt, der opfyldte QC-kriterier

25. juni 2015

Først opslået (Skøn)

30. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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