Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

19 grudnia 2018 zaktualizowane przez: Pfizer

A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

119

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hongkong
      • New Territories, Hongkong
        • Department of Clinical Oncology, Tuen Mun Hospital
      • Shatin, NT, Hongkong
        • Prince of Wales Hospital
    • NEW Territories
      • Tuen Mun, NEW Territories, Hongkong
        • Department of Clinical Oncology, Tuen Mun Hospital
      • Tuen Mun, NEW Territories, Hongkong
        • Department of Clinical Oncology, Tuen Mun Hospital
  • Japonia
      • Aichi, Japonia, 464-8681
        • Aichi cancer center central hospital Thoracic Oncology
    • Tokyo
      • Koto-Ku, Tokyo, Japonia, 135-8550
        • The Cancer Institute Hospital of JFCR
  • Republika Korei
      • Seoul, Republika Korei, 110-744
        • Seoul National University Hospital
      • Seoul, Republika Korei, 120-752
        • Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
      • Seoul, Republika Korei, 135-710
        • SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
  • Stany Zjednoczone
    • California
      • Orange, California, Stany Zjednoczone, 92868-3298
        • University of California, Irvine
      • Orange, California, Stany Zjednoczone, 92868
        • Chao Family Comprehensive Cancer Center UC Irvine Medical Center
      • Pleasant Hill, California, Stany Zjednoczone, 94523
        • Bay Area Cancer Research Group, LLC
      • Salinas, California, Stany Zjednoczone, 93901
        • Pacific Cancer Care
      • San Francisco, California, Stany Zjednoczone, 94110
        • San Francisco General Hospital
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Clinical Trials Office (CTO)
    • Florida
      • Fort Myers, Florida, Stany Zjednoczone, 33919
        • Florida Cancer Specialists
    • Maryland
      • Bethesda, Maryland, Stany Zjednoczone, 20892
        • National Institutes of Health National Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Brigham & Women's Hospital
      • Boston, Massachusetts, Stany Zjednoczone, 02210
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Stany Zjednoczone, 02210
        • Dana-Farber Cancer lnstitute
    • Missouri
      • Springfield, Missouri, Stany Zjednoczone, 65804
        • St. John's Hospital,
    • New York
      • New York, New York, Stany Zjednoczone, 10022
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, Stany Zjednoczone, 11794-9446
        • Stony Brook University Medical Center - Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27514
        • Investigational Drug Service, Pharmacy Department, UNC Hospitals
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7600
        • UNC Hospitals, The University of North Carolina at Chapel Hill
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-2008
        • Division of Hemotology/Oncology
      • Durham, North Carolina, Stany Zjednoczone, 27710
        • Morris Cancer Center
    • North Dakota
      • Bismarck, North Dakota, Stany Zjednoczone, 58501
        • Legacy Pharma Research
      • Bismarck, North Dakota, Stany Zjednoczone, 58501
        • Mid Dakota Clinic, P.C
    • Tennessee
      • Chattanooga, Tennessee, Stany Zjednoczone, 37404
        • Chattanooga Oncology & Hematology Associates, P.C.
      • Nashville, Tennessee, Stany Zjednoczone, 37203 (Administration)
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, Stany Zjednoczone, 37203(Pharmacy)
        • Sarah Cannon Research Institute
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone, 23230
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Stany Zjednoczone, 98195
        • University of Washington Medical Center
  • Tajwan
      • Taipei, Tajwan, 100
        • National Taiwan University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Advanced adenocarcinoma of lung, measurable disease
  • Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  • patients with known EGFR activating mutation regardless of smoking status
  • ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion Criteria:

  • Active brain metastases
  • Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  • known EGFR wild type NSCLC

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Lek: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
Lek: Dacomitinib (PF-00299804)
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
Eksperymentalny: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Lek: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
Lek: Dacomitinib (PF-00299804)
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression-Free Survival (PFS) at Month 4: Cohort A
Ramy czasowe: Baseline up to Month 4
PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
Baseline up to Month 4

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression-Free Survival (PFS) at Month 4: Cohort B
Ramy czasowe: Baseline up to Month 4
PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
Baseline up to Month 4
Progression-Free Survival (PFS)
Ramy czasowe: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.
Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Best Overall Response (BOR)
Ramy czasowe: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.
Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Duration of Response (DR)
Ramy czasowe: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.
Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Overall Survival (OS)
Ramy czasowe: Randomization until death or last date known to be alive.
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Randomization until death or last date known to be alive.
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Ramy czasowe: Baseline (Cycle [C]1 Day 1), up to C75
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.
Baseline (Cycle [C]1 Day 1), up to C75
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
Ramy czasowe: Baseline (C1D1) up to C75
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.
Baseline (C1D1) up to C75
Trough Plasma Concentrations (Ctrough) of Dacomitinib
Ramy czasowe: Predose on C1D14, C2D1, C3D1, C4D1
Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).
Predose on C1D14, C2D1, C3D1, C4D1

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

11 marca 2009

Zakończenie podstawowe (Rzeczywisty)

27 kwietnia 2012

Ukończenie studiów (Rzeczywisty)

30 kwietnia 2015

Daty rejestracji na studia

Pierwszy przesłany

5 stycznia 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 stycznia 2009

Pierwszy wysłany (Oszacować)

7 stycznia 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 stycznia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 grudnia 2018

Ostatnia weryfikacja

1 grudnia 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A7471017
  • 2011-002794-39 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Carcinoma, Non-small Cell

Badania kliniczne na Dacomitinib (PF-00299804)

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Congo

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj