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ID

14958

Description

AZD8186 First Time In Patient Ascending Dose Study; ODM derived from: https://clinicaltrials.gov/show/NCT01884285

Lien

https://clinicaltrials.gov/show/NCT01884285

Mots-clés

  1. 09/05/2016 09/05/2016 -
Téléchargé le

9 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285

    Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    provision of signed and dated, written informed consent prior to any study specific procedures
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    male or female, aged 18 years and older
    Description

    age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    histologically or cytologically proven diagnosis of prostate cancer, squamous non small cell lung cancer (sqnsclc), triple negative breast cancer (tnbc), or a known pten-deficient solid malignancy, that is refractory to standard therapies
    Description

    prostate cancer, squamous non small cell lung cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0600139 (Prostate carcinoma)
    SNOMED
    254900004
    UMLS CUI [2]
    C0007131 (Non-Small Cell Lung Carcinoma)
    SNOMED
    254637007
    females should be using adequate contraceptive measures (see section 4.3), should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential
    Description

    Contraceptive measures

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    world health organisation (who)/ecog performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
    Description

    ecog performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    treatment before study with (a) nitrosourea or mitomycin c; (b) investigational agents from a previous clinical study; (c) chemotherapy, immunotherapy or anticancer agents; (d) hormonal therapy (e.g., steroids)
    Description

    nitrosourea

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0028210 (Nitrosourea Compounds)
    SNOMED
    349843000
    UMLS CUI [2]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    treatment before study with (a) strong inhibitors and strong or moderate inducers of cyp3a4 (b) radiotherapy with a wide field of radiation
    Description

    strong inhibitors and strong or moderate inducers of cyp3a4

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1142644 (cytochrome P450 3A4 protein, human)
    UMLS CUI [2]
    C0034619 (radiotherapeutic)
    with the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events grade 1 at the time of study treatment
    Description

    alopecia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0002170 (Alopecia)
    SNOMED
    56317004
    spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids
    Description

    spinal cord compression or brain metastases

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0037926 (Compression of spinal cord)
    SNOMED
    71286001
    UMLS CUI [2]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    any evidence of severe or uncontrolled systemic diseases including active liver disease (other than malignancy), active bleeding diatheses, or active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv).
    Description

    systemic disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0442893 (Systemic disease)
    SNOMED
    56019007

    Similar models

    Eligibility Advanced Castrate-resistant Prostate Cancer (CRPC); NCT01884285

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    provision of signed and dated, written informed consent prior to any study specific procedures
    boolean
    C0021430 (UMLS CUI [1])
    age
    Item
    male or female, aged 18 years and older
    boolean
    C0001779 (UMLS CUI [1])
    prostate cancer, squamous non small cell lung cancer
    Item
    histologically or cytologically proven diagnosis of prostate cancer, squamous non small cell lung cancer (sqnsclc), triple negative breast cancer (tnbc), or a known pten-deficient solid malignancy, that is refractory to standard therapies
    boolean
    C0600139 (UMLS CUI [1])
    C0007131 (UMLS CUI [2])
    Contraceptive measures
    Item
    females should be using adequate contraceptive measures (see section 4.3), should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential
    boolean
    C0700589 (UMLS CUI [1])
    ecog performance status
    Item
    world health organisation (who)/ecog performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    nitrosourea
    Item
    treatment before study with (a) nitrosourea or mitomycin c; (b) investigational agents from a previous clinical study; (c) chemotherapy, immunotherapy or anticancer agents; (d) hormonal therapy (e.g., steroids)
    boolean
    C0028210 (UMLS CUI [1])
    C0279025 (UMLS CUI [2])
    strong inhibitors and strong or moderate inducers of cyp3a4
    Item
    treatment before study with (a) strong inhibitors and strong or moderate inducers of cyp3a4 (b) radiotherapy with a wide field of radiation
    boolean
    C1142644 (UMLS CUI [1])
    C0034619 (UMLS CUI [2])
    alopecia
    Item
    with the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events grade 1 at the time of study treatment
    boolean
    C0002170 (UMLS CUI [1])
    spinal cord compression or brain metastases
    Item
    spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids
    boolean
    C0037926 (UMLS CUI [1])
    C0220650 (UMLS CUI [2])
    systemic disease
    Item
    any evidence of severe or uncontrolled systemic diseases including active liver disease (other than malignancy), active bleeding diatheses, or active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv).
    boolean
    C0442893 (UMLS CUI [1])

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