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ID

42142

Beskrivning

A Study of ARQ 197 in Combination With Erlotinib; ODM derived from: https://clinicaltrials.gov/show/NCT01251796

Länk

https://clinicaltrials.gov/show/NCT01251796

Nyckelord

  1. 5/29/16 5/29/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uppladdad den

April 13, 2021

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

    Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    voluntary written informed consent for study participation must be obtained
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
    Beskrivning

    non-small-cell lung cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen)
    Beskrivning

    chemotherapy regimen

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1443775
    ecog ps of 0 or 1
    Beskrivning

    ecog

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of ≥3 months
    Beskrivning

    life expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    poor metabolizers as defined by cyp2c19 genotype
    Beskrivning

    CYP2 gene

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1332828
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    anti-cancer chemotherapy, anti-cancer therapy with egfr-tki, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to arq 197 dose
    Beskrivning

    egfr-tki

    Datatyp

    boolean

    surgery for cancer within 28 days prior to arq 197 dose
    Beskrivning

    cancer surgery

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0920424
    active double cancer
    Beskrivning

    Multiple malignancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0346429
    known symptomatic brain metastases
    Beskrivning

    brain metastases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
    Beskrivning

    intercurrent illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3640977
    pregnant or lactating
    Beskrivning

    pregnant or lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    subjects who wish to have a child and who would not agree to use contraceptive measures
    Beskrivning

    contraceptive measures

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589

    Similar models

    Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    voluntary written informed consent for study participation must be obtained
    boolean
    C0021430 (UMLS CUI [1])
    non-small-cell lung cancer
    Item
    a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
    boolean
    C0007131 (UMLS CUI [1])
    chemotherapy regimen
    Item
    history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen)
    boolean
    C0392920 (UMLS CUI [1,1])
    C1443775 (UMLS CUI [1,2])
    ecog
    Item
    ecog ps of 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    life expectancy
    Item
    life expectancy of ≥3 months
    boolean
    C0023671 (UMLS CUI [1])
    CYP2 gene
    Item
    poor metabolizers as defined by cyp2c19 genotype
    boolean
    C1332828 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    egfr-tki
    Item
    anti-cancer chemotherapy, anti-cancer therapy with egfr-tki, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to arq 197 dose
    boolean
    cancer surgery
    Item
    surgery for cancer within 28 days prior to arq 197 dose
    boolean
    C0920424 (UMLS CUI [1])
    Multiple malignancy
    Item
    active double cancer
    boolean
    C0346429 (UMLS CUI [1])
    brain metastases
    Item
    known symptomatic brain metastases
    boolean
    C0220650 (UMLS CUI [1])
    intercurrent illness
    Item
    an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
    boolean
    C3640977 (UMLS CUI [1])
    pregnant or lactating
    Item
    pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    contraceptive measures
    Item
    subjects who wish to have a child and who would not agree to use contraceptive measures
    boolean
    C0700589 (UMLS CUI [1])

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