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

17 januari 2021 bijgewerkt door: 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).

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

162

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
      • Darlinghurst, Australië
        • Research Site
      • Fitzroy, Australië
        • Research Site
      • Frankston, Australië
        • Research Site
      • Kogarah, Australië
        • Research Site
      • St Albans, Australië
        • Research Site
      • Woolloongabba, Australië
        • Research Site
  • Canada
      • Toronto, Canada
        • Research Site
  • Duitsland
      • Berlin, Duitsland
        • Research Site
      • Homburg, Duitsland
        • Research Site
      • Leipzig, Duitsland
        • Research Site
      • München, Duitsland
        • Research Site
      • Ulm, Duitsland
        • Research Site
  • Filippijnen
      • Cebu, Filippijnen
        • Research Site
    • Kalakhang Maynila
      • Makati, Kalakhang Maynila, Filippijnen
        • Research Site
    • Manila
      • Pasig, Manila, Filippijnen
        • Research Site
    • Metro Manila
      • Manila, Metro Manila, Filippijnen
        • Research Site 2
      • Manila, Metro Manila, Filippijnen
        • Research Site
  • Italië
      • Bergamo, Italië
        • Research Site
      • Bologna, Italië
        • Research Site
      • Catania, Italië
        • Research Site
      • Milano, Italië
        • Research Site
      • Rome, Italië
        • Research Site
  • Korea, republiek van
      • Cheongju-si, Korea, republiek van
        • Research Site
      • Goyang-si, Korea, republiek van
        • Research Site
      • Hwasun, Korea, republiek van
        • Research Site
      • Incheon, Korea, republiek van
        • Research Site
      • Seongnam-si, Korea, republiek van
        • Research Site 2
      • Seongnam-si, Korea, republiek van
        • Research Site
      • Seoul, Korea, republiek van
        • Research Site
      • Seoul, Korea, republiek van
        • Research Site 2
      • Seoul, Korea, republiek van
        • Research Site 3
      • Seoul, Korea, republiek van
        • Research Site 4
      • Seoul, Korea, republiek van
        • Research Site 5
      • Seoul, Korea, republiek van
        • Research Site 6
      • Seoul, Korea, republiek van
        • Research Site 7
      • Seoul, Korea, republiek van
        • Research Site 8
  • Maleisië
      • Kuala Lumpur, Maleisië
        • Research Site
      • Kuantan, Maleisië
        • Research Site
      • Kuching, Maleisië
        • Research Site
    • Penang
      • George Town, Penang, Maleisië
        • Research Site
  • Spanje
      • Barcelona, Spanje
        • Research Site
      • Barcelona, Spanje
        • Research Site 2
      • Barcelona, Spanje
        • Research Site 3
      • Barcelona, Spanje
        • Research Site 4
      • La Coruna, Spanje
        • Research Site
      • Madrid, Spanje
        • Research Site
      • Madrid, Spanje
        • Research Site 2
      • Navarra, Spanje
        • Research Site
      • San Sebastian, Spanje
        • Research Site
      • Valencia, Spanje
        • Research Site
      • Valencia, Spanje
        • 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
  • Verenigde Staten
    • California
      • Beverly Hills, California, Verenigde Staten
        • Research Site
      • Burbank, California, Verenigde Staten
        • Research Site
      • Los Angeles, California, Verenigde Staten
        • Research Site
      • Los Angeles, California, Verenigde Staten
        • Research Site 2
      • Montebello, California, Verenigde Staten
        • Research Site
      • Orange, California, Verenigde Staten
        • Research Site
      • San Diego, California, Verenigde Staten
        • Research Site
    • Florida
      • Boca Raton, Florida, Verenigde Staten
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten
        • Research Site
    • Illinois
      • Evanston, Illinois, Verenigde Staten
        • Research Site
    • Maryland
      • Bethesda, Maryland, Verenigde Staten
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, Verenigde Staten
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten
        • Research Site
    • Washington
      • Washington, Washington, Verenigde Staten
        • Research Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
Geneesmiddel: 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.
Andere namen:
  • Olmutinib

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective response rate (ORR)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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).
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hanmi Pharmaceutical Company Limited

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 augustus 2015

Primaire voltooiing (Werkelijk)

8 december 2020

Studie voltooiing (Werkelijk)

8 december 2020

Studieregistratiedata

Eerst ingediend

22 juni 2015

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2015

Eerst geplaatst (Schatting)

30 juni 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 januari 2021

Laatste update ingediend die voldeed aan QC-criteria

17 januari 2021

Laatst geverifieerd

1 januari 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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