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

19 december 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

119

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Läkemedel: 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).
Läkemedel: 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.
Experimentell: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Läkemedel: 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).
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS) at Month 4: Cohort A
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS) at Month 4: Cohort B
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 mars 2009

Primärt slutförande (Faktisk)

27 april 2012

Avslutad studie (Faktisk)

30 april 2015

Studieregistreringsdatum

Först inskickad

5 januari 2009

Först inskickad som uppfyllde QC-kriterierna

6 januari 2009

Första postat (Uppskatta)

7 januari 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 december 2018

Senast verifierad

1 december 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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