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

keskiviikko 19. joulukuuta 2018 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

119

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Lääke: 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).
Lääke: 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.
Kokeellinen: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Lääke: 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).
Lääke: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Progression-Free Survival (PFS) at Month 4: Cohort A
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Progression-Free Survival (PFS) at Month 4: Cohort B
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 11. maaliskuuta 2009

Ensisijainen valmistuminen (Todellinen)

Perjantai 27. huhtikuuta 2012

Opintojen valmistuminen (Todellinen)

Torstai 30. huhtikuuta 2015

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 5. tammikuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 6. tammikuuta 2009

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 7. tammikuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 8. tammikuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 19. joulukuuta 2018

Viimeksi vahvistettu

Lauantai 1. joulukuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Dacomitinib (PF-00299804)

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