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临床试验/EUCTR2013-002620-17-BE
EUCTR2013-002620-17-BE进行中（未招募）1 期

Phase 1/2 study of PF-06463922 (an ALK/ROS1 tyrosine kinase inhibitor) in patients with advanced non-small cell lung cancer harboring specific molecular alterations.

Pfizer Inc, 235 East 42nd Street, New York, NY 100170 个研究点目标入组 332 人开始时间: 2015年1月29日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
332
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT-PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). A central laboratory confirmation by a Sponsor-selected, validated test will retrospectively determine final ROS1 status. All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment.
  • •2. Disease Status Requirements
  • •Phase 1: ALK- positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after at least 1 previous ALK inhibitor therapy (ies).
  • •Phase 2: ALK -positive NSCLC patients must either be or have had:
  • •- Treatment naïve (ie, no prior chemotherapy in the metastatic disease
  • •setting and no prior ALK inhibitor therapy allowed) [EXP-1];
  • •- Disease progression after crizotinib only. No prior chemotherapy is
  • •allowed in the metastatic disease setting. [EXP-2];
  • •- Disease progression after crizotinib and 1 or 2 prior regimens of
  • •chemotherapy in the metastatic disease setting. [EXP-3];
  • •- Disease progression after 1 prior ALK inhibitor therapy other than
  • •crizotinib. Patients may have had any number of prior chemotherapy
  • •regimens in any disease setting. [EXP-3];
  • •- Disease progression after 2 prior ALK inhibitor therapies. Patients may
  • •have had any number of prior chemotherapy regimens in any disease
  • •setting. [EXP-4];
  • •- Disease progression after 3 prior ALK inhibitor therapies. Patients may
  • •have had any number of prior chemotherapy regimens in any disease
  • •setting. [EXP-5];
  • •ROS1- positive NSCLC patients may be:
  • •- Treatment naïve (ie, no prior chemotherapy in the metastatic disease
  • •setting and no prior ROS inhibitor therapy). [EXP-6];
  • •- Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor
  • •therapies). [EXP-6].
  • •3. Tumor Requirements:
  • •Phase 1: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. The brain metastases may be newly diagnosed or be present as progressive disease after surgery, whole brain radiotherapy or stereotactic radiosurgery (see Exclusion Criterion #3 for the lapsed time period required between the end of radiotherapy and study entry). Patients who have asymptomatic radiologically suspected leptomeningeal disease (LM) or carcinomatous meningitis (CM) and negative spinal fluid (CSF) are eligible to enter Phase 1.
  • •Phase 2: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. The brain metastases may be newly diagnosed or be present as progressive disease after surgery, whole brain radiotherapy or stereotactic radiosurgery (see Exclusion Criterion #3 for the lapsed time period required between the end of radiotherapy and study entry). Patients who have leptomeningeal disease (LM) or carcinomatous m

排除标准

  • •1.Spinal cord compression is excluded unless the patient demonstrates good pain control attained through therapy and there is stabilization or recovery of neurological function for the 4 weeks prior to study entry
  • •2.Major surgery within 4 weeks of study entry.Minor surgical procedures are not excluded but sufficient time should have passed for wound healing
  • •3.Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry.Palliative radiation (<=10 fractions) must have been completed at least 48 hours prior to study entry.Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry.Whole brain radiation must have completed at least 4 weeks prior to study entry
  • •4.Systemic anti-cancer therapy completed within a minimum of 5 half lives of study entry. Whole brain radiation must have completed at least 4
  • •weeks prior to study entry (unless clinically meaningful tumor flare per
  • •discretion of the investigator, in which discussion with the sponsor is warranted) .
  • •5.Prior therapy with an antibody or drug specifically targeting T-cell
  • •costimulation or immune checkpoint pathways, including, but not limited
  • •to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T
  • •lymphocyte associated antigen 4 (anti-CTLA-4) antibody.
  • •6.Previous high-dose chemotherapy requiring stem cell rescue
  • •7.Prior irradiation to >25% of the bone marrow
  • •8.Active and clinically significant bacterial, fungal, or viral infection
  • •including HBV, HCV, known HIV or AIDS-related illness
  • •9. Clinically significant cardiovascular disease (that is, active or <3
  • •months prior to enrollment): cerebral vascular accident/stroke,
  • •myocardial infarction, unstable angina, congestive heart failure (New
  • •York Heart Association Classification Class = II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec.
  • •Ongoing cardiac dysrhythmias of NCI CTCAE Grade =2, uncontrolled
  • •atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless
  • •patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome.
  • •10.Patients with predisposing characteristics for acute pancreatitis
  • •according to investigator judgment (see protocol for more details).
  • •11.History of extensive,disseminated,bilateral or presence of Grade 3 or
  • •4 interstitial fibrosis or interstitial lung disease including a history of
  • •pneumonitis, hypersentivity pneumonitis, interstitial pneumonia,
  • •interstitial lung disease, obliterative bronchiolitis and pulmonary
  • •fibrosis. Patients with history of prior radiation pneumonitis are not
  • •12.Other severe acute or chronic medical or psychiatric
  • •condition,including recent (within the past year) or active suicidal
  • •ideation or behavior,or laboratory abnormality that may increase the risk
  • •associated with study participation or investigational product
  • •administration or may interfere with the interpretation of study results
  • •and,in the judgment of the investigator,would make the patient
  • •inappropriate for entry into this study
  • •13.Patients who are investigational site staff members directly involved
  • •in the conduct of the trial and their family members,site staff members
  • •otherwise supervised by the Investigator,or patients who are Pfizer
  • •employees directly involved in the conduct of the trial
  • •14.Evidence of active malignancy within the last 3 years. See protocol
  • •for more details

研究者

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已完成
1 期
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular AlterationsALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
NCT01970865Pfizer364