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ID

33930

Beskrivning

A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02328261

Länk

https://clinicaltrials.gov/show/NCT02328261

Nyckelord

Versioner (1)
  1. 2019-01-08 2019-01-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 januari 2019

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Nasopharyngeal Carcinoma NCT02328261

    Engelsk

    Eligibility Nasopharyngeal Carcinoma NCT02328261

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically confirmed advanced npc
    Beskrivning

    Nasopharyngeal carcinoma Advanced

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2931822
    UMLS CUI [1,2]
    C0205179
    patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
    Beskrivning

    Platinum Resistant | Recurrent disease | Disease Progression

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032207
    UMLS CUI [1,2]
    C0332325
    UMLS CUI [2]
    C0277556
    UMLS CUI [3]
    C0242656
    measurable disease per recist
    Beskrivning

    Measurable Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    adequate organ and marrow function
    Beskrivning

    Organ function | Bone Marrow function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2,1]
    C0005953
    UMLS CUI [2,2]
    C0031843
    capable of understanding and complying with the protocol, and written informed consent
    Beskrivning

    Protocol Compliance | Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior treatment with gefitinib, erlotinib, or other drugs that target egfr
    Beskrivning

    gefitinib | erlotinib | Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1122962
    UMLS CUI [2]
    C1135135
    UMLS CUI [3,1]
    C0013227
    UMLS CUI [3,2]
    C1521840
    UMLS CUI [3,3]
    C0034802
    patients must not be receiving any other investigational agents
    Beskrivning

    Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
    Beskrivning

    Illness Serious Treatment required for | Medical condition Treatment required for | Heart Diseases Unstable | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease Uncontrolled

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C0332121
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0332121
    UMLS CUI [3,1]
    C0018799
    UMLS CUI [3,2]
    C0443343
    UMLS CUI [4]
    C0027765
    UMLS CUI [5]
    C0004936
    UMLS CUI [6]
    C0033975
    UMLS CUI [7]
    C0497327
    UMLS CUI [8]
    C0036572
    UMLS CUI [9,1]
    C0009450
    UMLS CUI [9,2]
    C0205318
    women who are pregnant or breast-feeding
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
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    Similar models

    Eligibility Nasopharyngeal Carcinoma NCT02328261

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Nasopharyngeal carcinoma Advanced
    Item
    histologically confirmed advanced npc
    boolean
    C2931822 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    Platinum Resistant | Recurrent disease | Disease Progression
    Item
    patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
    boolean
    C0032207 (UMLS CUI [1,1])
    C0332325 (UMLS CUI [1,2])
    C0277556 (UMLS CUI [2])
    C0242656 (UMLS CUI [3])
    Measurable Disease
    Item
    measurable disease per recist
    boolean
    C1513041 (UMLS CUI [1])
    Organ function | Bone Marrow function
    Item
    adequate organ and marrow function
    boolean
    C0678852 (UMLS CUI [1])
    C0005953 (UMLS CUI [2,1])
    C0031843 (UMLS CUI [2,2])
    Protocol Compliance | Informed Consent
    Item
    capable of understanding and complying with the protocol, and written informed consent
    boolean
    C0525058 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    gefitinib | erlotinib | Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor
    Item
    prior treatment with gefitinib, erlotinib, or other drugs that target egfr
    boolean
    C1122962 (UMLS CUI [1])
    C1135135 (UMLS CUI [2])
    C0013227 (UMLS CUI [3,1])
    C1521840 (UMLS CUI [3,2])
    C0034802 (UMLS CUI [3,3])
    Investigational New Drugs
    Item
    patients must not be receiving any other investigational agents
    boolean
    C0013230 (UMLS CUI [1])
    Illness Serious Treatment required for | Medical condition Treatment required for | Heart Diseases Unstable | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease Uncontrolled
    Item
    other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0332121 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    C0018799 (UMLS CUI [3,1])
    C0443343 (UMLS CUI [3,2])
    C0027765 (UMLS CUI [4])
    C0004936 (UMLS CUI [5])
    C0033975 (UMLS CUI [6])
    C0497327 (UMLS CUI [7])
    C0036572 (UMLS CUI [8])
    C0009450 (UMLS CUI [9,1])
    C0205318 (UMLS CUI [9,2])
    Pregnancy | Breast Feeding
    Item
    women who are pregnant or breast-feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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