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

2018年12月19日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

119

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
药品：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).
药品：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.
实验性的：Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
药品：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).
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) at Month 4: Cohort A
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) at Month 4: Cohort B
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年3月11日

初级完成 (实际的)

2012年4月27日

研究完成 (实际的)

2015年4月30日

研究注册日期

首次提交

2009年1月5日

首先提交符合 QC 标准的

2009年1月6日

首次发布 (估计)

2009年1月7日

研究记录更新

最后更新发布 (实际的)

2019年1月8日

上次提交的符合 QC 标准的更新

2018年12月19日

最后验证

2018年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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