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ID

14796

Descrizione

Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT02260661

collegamento

https://clinicaltrials.gov/show/NCT02260661

Keywords

versioni (1)
  1. 28/04/16 28/04/16 -
Caricato su

28 aprile 2016

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Advanced Solid Malignancies NCT02260661

    Inglese

    Eligibility Advanced Solid Malignancies NCT02260661

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    understand the nature of the trial and provide signed and dated written consent
    Descrizione

    informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    histological or cytological confirmation of a solid tumor and disease progression
    Descrizione

    solid tumor

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0280100
    histological or cytological confirmation of er+her2- negative breast cancer and disease progression or any other solid tumor with a pik3ca gene mutation
    Descrizione

    breast cancer

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C1335212
    histological or cytological confirmation of er+her2- negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment
    Descrizione

    postmenopausal

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    histological or cytological confirmation of er+her2- negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. patients must also present with a tumor related mutation of the pik3ca gene.
    Descrizione

    metastatic disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0936223
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    recent chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half-days from enrolment
    Descrizione

    chemotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    received palliative/focal radiotherapy within 2 weeks of first dose of study treatment
    Descrizione

    radiotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    major surgery less than or equal to 21 days from beginning of study drug
    Descrizione

    major surgery

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    any of the following cardiac criteria: chf > class ii, cardiac ventricular arrhythmia requiring therapy, unstable angina, qtcf interval >470ms, abnormal echo or muga at baseline (lvef <50%)
    Descrizione

    ventricular arrhythmia, unstable angina

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0085612
    UMLS CUI [2]
    C0002965
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    Similar models

    Eligibility Advanced Solid Malignancies NCT02260661

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    understand the nature of the trial and provide signed and dated written consent
    boolean
    C0021430 (UMLS CUI [1])
    solid tumor
    Item
    histological or cytological confirmation of a solid tumor and disease progression
    boolean
    C0280100 (UMLS CUI [1])
    breast cancer
    Item
    histological or cytological confirmation of er+her2- negative breast cancer and disease progression or any other solid tumor with a pik3ca gene mutation
    boolean
    C0678222 (UMLS CUI [1,1])
    C1335212 (UMLS CUI [1,2])
    postmenopausal
    Item
    histological or cytological confirmation of er+her2- negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment
    boolean
    C0232970 (UMLS CUI [1])
    metastatic disease
    Item
    histological or cytological confirmation of er+her2- negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. patients must also present with a tumor related mutation of the pik3ca gene.
    boolean
    C0936223 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    chemotherapy
    Item
    recent chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half-days from enrolment
    boolean
    C0392920 (UMLS CUI [1])
    radiotherapy
    Item
    received palliative/focal radiotherapy within 2 weeks of first dose of study treatment
    boolean
    C1522449 (UMLS CUI [1])
    major surgery
    Item
    major surgery less than or equal to 21 days from beginning of study drug
    boolean
    C0679637 (UMLS CUI [1])
    ventricular arrhythmia, unstable angina
    Item
    any of the following cardiac criteria: chf > class ii, cardiac ventricular arrhythmia requiring therapy, unstable angina, qtcf interval >470ms, abnormal echo or muga at baseline (lvef <50%)
    boolean
    C0085612 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    Ritorna all'inizio della pagina 

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