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ID

42142

Description

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

Lien

https://clinicaltrials.gov/show/NCT01251796

Mots-clés

Versions (2)
  1. 29/05/2016 29/05/2016 -
  2. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
Téléchargé le

13 avril 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

    Anglais

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

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    voluntary written informed consent for study participation must be obtained
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
    Description

    non-small-cell lung cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007131 (Non-Small Cell Lung Carcinoma)
    SNOMED
    254637007
    history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen)
    Description

    chemotherapy regimen

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [1,2]
    C1443775 (Epidermal growth factor receptor inhibitor (product))
    SNOMED
    409402009
    ecog ps of 0 or 1
    Description

    ecog

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of ≥3 months
    Description

    life expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    poor metabolizers as defined by cyp2c19 genotype
    Description

    CYP2 gene

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1332828 (CYP2C19 gene)
    LOINC
    LP97107-4
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    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
    Description

    egfr-tki

    Type de données

    boolean

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

    cancer surgery

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0920424 (cancer surgery)
    active double cancer
    Description

    Multiple malignancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0346429 (Multiple malignancy)
    SNOMED
    363500001
    known symptomatic brain metastases
    Description

    brain metastases

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
    Description

    intercurrent illness

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3640977 (Significant Intercurrent Illness)
    pregnant or lactating
    Description

    pregnant or lactating

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    subjects who wish to have a child and who would not agree to use contraceptive measures
    Description

    contraceptive measures

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Retour au début de la page

    Similar models

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

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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