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ID

15677

Descrição

Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT02292550

Link

https://clinicaltrials.gov/show/NCT02292550

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Versões (1)
  1. 08/06/2016 08/06/2016 -
Transferido a

8 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Non-small Cell Lung Cancer NCT02292550

    Inglês

    Eligibility Non-small Cell Lung Cancer NCT02292550

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients must be diagnosed with alk-positive advanced nsclc. the tumor must be alk-positive as determined by alk rearrangement in ≥15% of cells (as measured by fish using the vysis break-apart alk probe) or by using the ventana alk ihc test. the analysis may be performed locally.
    Descrição

    Non-Small Cell Lung Carcinoma Advanced ALK gene rearrangement positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0007131
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [1,3]
    C3888914
    eastern cooperative oncology group (ecog) performance status ≤ 2.
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    measurable disease as per recist v1.1
    Descrição

    Measurable Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    availability of tumor sample:
    Descrição

    Tumor tissue sample Availability

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0470187
    for alk inhibitor naïve patients:
    Descrição

    Anaplastic lymphoma kinase Inhibitor | Therapy naive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0252409
    UMLS CUI [1,2]
    C1999216
    UMLS CUI [2]
    C0919936
    o a representative tumor sample must be submitted. an archival tumor specimen is acceptable
    Descrição

    Tumor tissue sample Representative

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C1882932
    for patients after progression on an alk inhibitor:
    Descrição

    anaplastic lymphoma kinase Inhibitor | Disease Progression

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0252409
    UMLS CUI [1,2]
    C1999216
    UMLS CUI [2]
    C0242656
    o a new tumor biopsy is required unless a biopsy performed after progression on the patient's most recent alk inhibitor is available for submission for all patients a newly obtained tumor specimen must be submitted if no appropriate archival sample is available. in the event that no sample is available and a new biopsy cannot be obtained, enrollment may be considered after discussion with the sponsor.
    Descrição

    Malignant Neoplasms Biopsy New | Tumor tissue sample New

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [1,3]
    C0205314
    UMLS CUI [2,1]
    C0475358
    UMLS CUI [2,2]
    C0205314
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    for phase ii part:
    Descrição

    Phase 2 Clinical Trial

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0282460
    group a: prior therapy with any alk inhibitor is not permitted.
    Descrição

    Group A | anaplastic lymphoma kinase Inhibitor | Prior Therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0441835
    UMLS CUI [2,1]
    C0252409
    UMLS CUI [2,2]
    C1999216
    UMLS CUI [3]
    C1514463
    group b: progression following any alk inhibitor(s) other than ceritinib is required and the last dose of the alk inhibitor must be no more than 60 days prior to the first dose of study drug. prior ceritinib is not permitted.
    Descrição

    Group B | Disease Progression | anaplastic lymphoma kinase Inhibitor | ceritinib

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0441836
    UMLS CUI [2]
    C0242656
    UMLS CUI [3,1]
    C0252409
    UMLS CUI [3,2]
    C1999216
    UMLS CUI [4]
    C3818721
    group c: progression following ceritinib is required and the last dose of ceritinib must be no more than 60 days prior to the first dose of study drug.
    Descrição

    Group C | ceritinib | Disease Progression

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0441837
    UMLS CUI [2]
    C3818721
    UMLS CUI [3]
    C0242656
    patients who have previously received ceritinib must have tolerated a dose of ceritinib 600 mg qd, or greater.
    Descrição

    ceritinib Previous | ceritinib Dosage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3818721
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [2,1]
    C3818721
    UMLS CUI [2,2]
    C0178602
    patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or require increasing doses of steroids or local cns-directed therapy to control their cns disease
    Descrição

    CNS metastases Symptomatic Neurologic Unstable status | Steroids | Therapeutic procedure Central Nervous System

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [1,3]
    C0205494
    UMLS CUI [1,4]
    C0443343
    UMLS CUI [2]
    C0038317
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C3714787
    impaired cardiac function or any clinically significant cardiac disease
    Descrição

    Decreased cardiac function | Heart Diseases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0232166
    UMLS CUI [2]
    C0018799
    patients with abnormal laboratory values during screening and on day 1 of pre-dose
    Descrição

    Laboratory test result abnormal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of ceritinib or lee011
    Descrição

    gastrointestinal function Impaired | Gastrointestinal Diseases Affecting Absorption ceritinib | Gastrointestinal Diseases Affecting Absorption LEE011

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0516983
    UMLS CUI [1,2]
    C0221099
    UMLS CUI [2,1]
    C0017178
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0021826
    UMLS CUI [2,4]
    C3818721
    UMLS CUI [3,1]
    C0017178
    UMLS CUI [3,2]
    C0392760
    UMLS CUI [3,3]
    C0021826
    UMLS CUI [3,4]
    C2987342
    patients who are currently receiving treatment (that cannot be discontinued at least 1 week prior to the initiation of the study) with agents that are known to be any of the following: strong inducers or inhibitors of cyp3a4/5; sensitive substrates of cyp3a; substrates of cyp3a4/5 or cyp2c9 with a narrow therapeutic index.
    Descrição

    Therapeutic procedure | Cytochrome P450 3A4 Inducer | Cytochrome P450 3A4 Inhibitor | Cytochrome P-450 CYP3A5 Inducers | Cytochrome P-450 CYP3A5 Inhibitors | cytochrome P450 3A Substrate Sensitive | Cytochrome P-450 CYP3A4 Substrate Narrow Therapeutic Index | Cytochrome P-450 CYP3A5 Substrate Narrow Therapeutic Index | Cytochrome p450 CYP2 enzyme Substrate Narrow Therapeutic Index

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    UMLS CUI [2]
    C3830625
    UMLS CUI [3]
    C3830624
    UMLS CUI [4]
    C3850043
    UMLS CUI [5]
    C3850054
    UMLS CUI [6,1]
    C0059563
    UMLS CUI [6,2]
    C3891814
    UMLS CUI [6,3]
    C0332324
    UMLS CUI [7,1]
    C3714798
    UMLS CUI [7,2]
    C3891814
    UMLS CUI [7,3]
    C3889681
    UMLS CUI [8,1]
    C3714750
    UMLS CUI [8,2]
    C3891814
    UMLS CUI [8,3]
    C3889681
    UMLS CUI [9,1]
    C1828473
    UMLS CUI [9,2]
    C3891814
    UMLS CUI [9,3]
    C3889681
    patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
    Descrição

    Pancreatitis | Amylase increased | Lipase Due to Pancreatic Diseases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0030305
    UMLS CUI [2]
    C0151479
    UMLS CUI [3,1]
    C0023764
    UMLS CUI [3,2]
    C0678226
    UMLS CUI [3,3]
    C0030286
    other protocol-defined inclusion/exclusion criteria may apply.
    Descrição

    Inclusion Other | Exclusion Criteria Other

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C0680251
    UMLS CUI [2,2]
    C0205394
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    Similar models

    Eligibility Non-small Cell Lung Cancer NCT02292550

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Small Cell Lung Carcinoma Advanced ALK gene rearrangement positive
    Item
    patients must be diagnosed with alk-positive advanced nsclc. the tumor must be alk-positive as determined by alk rearrangement in ≥15% of cells (as measured by fish using the vysis break-apart alk probe) or by using the ventana alk ihc test. the analysis may be performed locally.
    boolean
    C0007131 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C3888914 (UMLS CUI [1,3])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status ≤ 2.
    boolean
    C1520224 (UMLS CUI [1])
    Measurable Disease
    Item
    measurable disease as per recist v1.1
    boolean
    C1513041 (UMLS CUI [1])
    Tumor tissue sample Availability
    Item
    availability of tumor sample:
    boolean
    C0475358 (UMLS CUI [1,1])
    C0470187 (UMLS CUI [1,2])
    Anaplastic lymphoma kinase Inhibitor | Therapy naive
    Item
    for alk inhibitor naïve patients:
    boolean
    C0252409 (UMLS CUI [1,1])
    C1999216 (UMLS CUI [1,2])
    C0919936 (UMLS CUI [2])
    Tumor tissue sample Representative
    Item
    o a representative tumor sample must be submitted. an archival tumor specimen is acceptable
    boolean
    C0475358 (UMLS CUI [1,1])
    C1882932 (UMLS CUI [1,2])
    anaplastic lymphoma kinase Inhibitor | Disease Progression
    Item
    for patients after progression on an alk inhibitor:
    boolean
    C0252409 (UMLS CUI [1,1])
    C1999216 (UMLS CUI [1,2])
    C0242656 (UMLS CUI [2])
    Malignant Neoplasms Biopsy New | Tumor tissue sample New
    Item
    o a new tumor biopsy is required unless a biopsy performed after progression on the patient's most recent alk inhibitor is available for submission for all patients a newly obtained tumor specimen must be submitted if no appropriate archival sample is available. in the event that no sample is available and a new biopsy cannot be obtained, enrollment may be considered after discussion with the sponsor.
    boolean
    C0006826 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C0205314 (UMLS CUI [1,3])
    C0475358 (UMLS CUI [2,1])
    C0205314 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Phase 2 Clinical Trial
    Item
    for phase ii part:
    boolean
    C0282460 (UMLS CUI [1])
    Group A | anaplastic lymphoma kinase Inhibitor | Prior Therapy
    Item
    group a: prior therapy with any alk inhibitor is not permitted.
    boolean
    C0441835 (UMLS CUI [1])
    C0252409 (UMLS CUI [2,1])
    C1999216 (UMLS CUI [2,2])
    C1514463 (UMLS CUI [3])
    Group B | Disease Progression | anaplastic lymphoma kinase Inhibitor | ceritinib
    Item
    group b: progression following any alk inhibitor(s) other than ceritinib is required and the last dose of the alk inhibitor must be no more than 60 days prior to the first dose of study drug. prior ceritinib is not permitted.
    boolean
    C0441836 (UMLS CUI [1])
    C0242656 (UMLS CUI [2])
    C0252409 (UMLS CUI [3,1])
    C1999216 (UMLS CUI [3,2])
    C3818721 (UMLS CUI [4])
    Group C | ceritinib | Disease Progression
    Item
    group c: progression following ceritinib is required and the last dose of ceritinib must be no more than 60 days prior to the first dose of study drug.
    boolean
    C0441837 (UMLS CUI [1])
    C3818721 (UMLS CUI [2])
    C0242656 (UMLS CUI [3])
    ceritinib Previous | ceritinib Dosage
    Item
    patients who have previously received ceritinib must have tolerated a dose of ceritinib 600 mg qd, or greater.
    boolean
    C3818721 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C3818721 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    CNS metastases Symptomatic Neurologic Unstable status | Steroids | Therapeutic procedure Central Nervous System
    Item
    patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or require increasing doses of steroids or local cns-directed therapy to control their cns disease
    boolean
    C0686377 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0205494 (UMLS CUI [1,3])
    C0443343 (UMLS CUI [1,4])
    C0038317 (UMLS CUI [2])
    C0087111 (UMLS CUI [3,1])
    C3714787 (UMLS CUI [3,2])
    Decreased cardiac function | Heart Diseases
    Item
    impaired cardiac function or any clinically significant cardiac disease
    boolean
    C0232166 (UMLS CUI [1])
    C0018799 (UMLS CUI [2])
    Laboratory test result abnormal
    Item
    patients with abnormal laboratory values during screening and on day 1 of pre-dose
    boolean
    C0438215 (UMLS CUI [1])
    gastrointestinal function Impaired | Gastrointestinal Diseases Affecting Absorption ceritinib | Gastrointestinal Diseases Affecting Absorption LEE011
    Item
    impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of ceritinib or lee011
    boolean
    C0516983 (UMLS CUI [1,1])
    C0221099 (UMLS CUI [1,2])
    C0017178 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0021826 (UMLS CUI [2,3])
    C3818721 (UMLS CUI [2,4])
    C0017178 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0021826 (UMLS CUI [3,3])
    C2987342 (UMLS CUI [3,4])
    Therapeutic procedure | Cytochrome P450 3A4 Inducer | Cytochrome P450 3A4 Inhibitor | Cytochrome P-450 CYP3A5 Inducers | Cytochrome P-450 CYP3A5 Inhibitors | cytochrome P450 3A Substrate Sensitive | Cytochrome P-450 CYP3A4 Substrate Narrow Therapeutic Index | Cytochrome P-450 CYP3A5 Substrate Narrow Therapeutic Index | Cytochrome p450 CYP2 enzyme Substrate Narrow Therapeutic Index
    Item
    patients who are currently receiving treatment (that cannot be discontinued at least 1 week prior to the initiation of the study) with agents that are known to be any of the following: strong inducers or inhibitors of cyp3a4/5; sensitive substrates of cyp3a; substrates of cyp3a4/5 or cyp2c9 with a narrow therapeutic index.
    boolean
    C0087111 (UMLS CUI [1])
    C3830625 (UMLS CUI [2])
    C3830624 (UMLS CUI [3])
    C3850043 (UMLS CUI [4])
    C3850054 (UMLS CUI [5])
    C0059563 (UMLS CUI [6,1])
    C3891814 (UMLS CUI [6,2])
    C0332324 (UMLS CUI [6,3])
    C3714798 (UMLS CUI [7,1])
    C3891814 (UMLS CUI [7,2])
    C3889681 (UMLS CUI [7,3])
    C3714750 (UMLS CUI [8,1])
    C3891814 (UMLS CUI [8,2])
    C3889681 (UMLS CUI [8,3])
    C1828473 (UMLS CUI [9,1])
    C3891814 (UMLS CUI [9,2])
    C3889681 (UMLS CUI [9,3])
    Pancreatitis | Amylase increased | Lipase Due to Pancreatic Diseases
    Item
    patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
    boolean
    C0030305 (UMLS CUI [1])
    C0151479 (UMLS CUI [2])
    C0023764 (UMLS CUI [3,1])
    C0678226 (UMLS CUI [3,2])
    C0030286 (UMLS CUI [3,3])
    Inclusion Other | Exclusion Criteria Other
    Item
    other protocol-defined inclusion/exclusion criteria may apply.
    boolean
    C1512693 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
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