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

17 janvier 2021 mis à jour par: 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).

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

162

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne
        • Research Site
      • Homburg, Allemagne
        • Research Site
      • Leipzig, Allemagne
        • Research Site
      • München, Allemagne
        • Research Site
      • Ulm, Allemagne
        • Research Site
  • Australie
      • Darlinghurst, Australie
        • Research Site
      • Fitzroy, Australie
        • Research Site
      • Frankston, Australie
        • Research Site
      • Kogarah, Australie
        • Research Site
      • St Albans, Australie
        • Research Site
      • Woolloongabba, Australie
        • Research Site
  • Canada
      • Toronto, Canada
        • Research Site
  • Corée, République de
      • Cheongju-si, Corée, République de
        • Research Site
      • Goyang-si, Corée, République de
        • Research Site
      • Hwasun, Corée, République de
        • Research Site
      • Incheon, Corée, République de
        • Research Site
      • Seongnam-si, Corée, République de
        • Research Site 2
      • Seongnam-si, Corée, République de
        • Research Site
      • Seoul, Corée, République de
        • Research Site
      • Seoul, Corée, République de
        • Research Site 2
      • Seoul, Corée, République de
        • Research Site 3
      • Seoul, Corée, République de
        • Research Site 4
      • Seoul, Corée, République de
        • Research Site 5
      • Seoul, Corée, République de
        • Research Site 6
      • Seoul, Corée, République de
        • Research Site 7
      • Seoul, Corée, République de
        • Research Site 8
  • Espagne
      • Barcelona, Espagne
        • Research Site
      • Barcelona, Espagne
        • Research Site 2
      • Barcelona, Espagne
        • Research Site 3
      • Barcelona, Espagne
        • Research Site 4
      • La Coruna, Espagne
        • Research Site
      • Madrid, Espagne
        • Research Site
      • Madrid, Espagne
        • Research Site 2
      • Navarra, Espagne
        • Research Site
      • San Sebastian, Espagne
        • Research Site
      • Valencia, Espagne
        • Research Site
      • Valencia, Espagne
        • Research Site 2
  • Italie
      • Bergamo, Italie
        • Research Site
      • Bologna, Italie
        • Research Site
      • Catania, Italie
        • Research Site
      • Milano, Italie
        • Research Site
      • Rome, Italie
        • Research Site
  • Malaisie
      • Kuala Lumpur, Malaisie
        • Research Site
      • Kuantan, Malaisie
        • Research Site
      • Kuching, Malaisie
        • Research Site
    • Penang
      • George Town, Penang, Malaisie
        • Research Site
  • Philippines
      • Cebu, Philippines
        • Research Site
    • Kalakhang Maynila
      • Makati, Kalakhang Maynila, Philippines
        • Research Site
    • Manila
      • Pasig, Manila, Philippines
        • Research Site
    • Metro Manila
      • Manila, Metro Manila, Philippines
        • Research Site 2
      • Manila, Metro Manila, Philippines
        • Research Site
  • Taïwan
      • Kaohsiung, Taïwan
        • Research Site
      • Taichung, Taïwan
        • Research Site
      • Tainan, Taïwan
        • Research Site
      • Tainan, Taïwan
        • Research Site 2
      • Taipei, Taïwan
        • Research Site
      • Taipei, Taïwan
        • Research Site 2
  • États-Unis
    • California
      • Beverly Hills, California, États-Unis
        • Research Site
      • Burbank, California, États-Unis
        • Research Site
      • Los Angeles, California, États-Unis
        • Research Site
      • Los Angeles, California, États-Unis
        • Research Site 2
      • Montebello, California, États-Unis
        • Research Site
      • Orange, California, États-Unis
        • Research Site
      • San Diego, California, États-Unis
        • Research Site
    • Florida
      • Boca Raton, Florida, États-Unis
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, États-Unis
        • Research Site
    • Illinois
      • Evanston, Illinois, États-Unis
        • Research Site
    • Maryland
      • Bethesda, Maryland, États-Unis
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, États-Unis
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, États-Unis
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, États-Unis
        • Research Site
    • Washington
      • Washington, Washington, États-Unis
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
Médicament: 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.
Autres noms:
  • Olmutinib

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Objective response rate (ORR)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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).
Délai: 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.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hanmi Pharmaceutical Company Limited

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 août 2015

Achèvement primaire (Réel)

8 décembre 2020

Achèvement de l'étude (Réel)

8 décembre 2020

Dates d'inscription aux études

Première soumission

22 juin 2015

Première soumission répondant aux critères de contrôle qualité

25 juin 2015

Première publication (Estimation)

30 juin 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 janvier 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 janvier 2021

Dernière vérification

1 janvier 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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