0 Avaliações
ID

24772

Descrição

Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00569114

Link

https://clinicaltrials.gov/show/NCT00569114

Palavras-chave

Versões (1)
  1. 16/08/2017 16/08/2017 -
Transferido a

16 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Non-small Cell Lung Cancer NCT00569114

    Inglês

    Eligibility Non-small Cell Lung Cancer NCT00569114

    1 Formulários  
    Criteria
    Descrição

    Criteria

    histogically or pathologically determined relapsed/recurrent stage iiib (plueral effusion) or iv nsclc.
    Descrição

    Non-small cell lung cancer recurrent TNM clinical staging | Pleural effusion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0278517
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2]
    C0032227
    measurable or evaluable disease as defined by recist
    Descrição

    Measurable Disease | Evaluable Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C1516986
    must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
    Descrição

    Chemotherapy Regimen Quantity failed | Chemotherapy Refused

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0231175
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C1705116
    ecog perfromance status of 0,1, or 2.
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    exclusion criteria (include but are not limited to):
    Descrição

    Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    radiation therapy (excluding cns therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
    Descrição

    Therapeutic radiology procedure | Exception Therapeutic procedure Central Nervous System | Chemotherapy | Investigational New Drugs Non-Cytotoxic | Adrenal Cortex Hormones High dose | Adverse effects of medical drugs Recovery Lacking

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C3714787
    UMLS CUI [3]
    C0392920
    UMLS CUI [4,1]
    C0013230
    UMLS CUI [4,2]
    C2827065
    UMLS CUI [5,1]
    C0001617
    UMLS CUI [5,2]
    C0444956
    UMLS CUI [6,1]
    C0810090
    UMLS CUI [6,2]
    C2004454
    UMLS CUI [6,3]
    C0332268
    evidence of new york heart associatation class iii or greater cardiac disease.
    Descrição

    Heart Disease New York Heart Association Classification

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C1275491
    history of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
    Descrição

    Myocardial Infarction | Cerebrovascular accident | Intervention Cardiovascular

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0038454
    UMLS CUI [3,1]
    C0184661
    UMLS CUI [3,2]
    C3887460
    patients on anti-platlet drugs or anticoagulants such as placix and coumadin.
    Descrição

    Antiplatelet Agents | Anticoagulants | Plavix | Coumadin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085826
    UMLS CUI [2]
    C0003280
    UMLS CUI [3]
    C0633084
    UMLS CUI [4]
    C0699129
    systemic central nervous system metastases. the patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
    Descrição

    CNS metastases Systemic | Stable status Post Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377
    UMLS CUI [1,2]
    C0205373
    UMLS CUI [2,1]
    C0205360
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C1522449
    UMLS CUI [3,1]
    C0001617
    UMLS CUI [3,2]
    C1444662
    pregnant or nursing women.
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    patients who are primarily refactory to erlotinib.
    Descrição

    Erlotinib Refractory Primary

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1135135
    UMLS CUI [1,2]
    C0205269
    UMLS CUI [1,3]
    C0205225
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    Similar models

    Eligibility Non-small Cell Lung Cancer NCT00569114

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Non-small cell lung cancer recurrent TNM clinical staging | Pleural effusion
    Item
    histogically or pathologically determined relapsed/recurrent stage iiib (plueral effusion) or iv nsclc.
    boolean
    C0278517 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C0032227 (UMLS CUI [2])
    Measurable Disease | Evaluable Disease
    Item
    measurable or evaluable disease as defined by recist
    boolean
    C1513041 (UMLS CUI [1])
    C1516986 (UMLS CUI [2])
    Chemotherapy Regimen Quantity failed | Chemotherapy Refused
    Item
    must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
    boolean
    C0392920 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [2,1])
    C1705116 (UMLS CUI [2,2])
    ECOG performance status
    Item
    ecog perfromance status of 0,1, or 2.
    boolean
    C1520224 (UMLS CUI [1])
    Exclusion Criteria
    Item
    exclusion criteria (include but are not limited to):
    boolean
    C0680251 (UMLS CUI [1])
    Therapeutic radiology procedure | Exception Therapeutic procedure Central Nervous System | Chemotherapy | Investigational New Drugs Non-Cytotoxic | Adrenal Cortex Hormones High dose | Adverse effects of medical drugs Recovery Lacking
    Item
    radiation therapy (excluding cns therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
    boolean
    C1522449 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C3714787 (UMLS CUI [2,3])
    C0392920 (UMLS CUI [3])
    C0013230 (UMLS CUI [4,1])
    C2827065 (UMLS CUI [4,2])
    C0001617 (UMLS CUI [5,1])
    C0444956 (UMLS CUI [5,2])
    C0810090 (UMLS CUI [6,1])
    C2004454 (UMLS CUI [6,2])
    C0332268 (UMLS CUI [6,3])
    Heart Disease New York Heart Association Classification
    Item
    evidence of new york heart associatation class iii or greater cardiac disease.
    boolean
    C0018799 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    Myocardial Infarction | Cerebrovascular accident | Intervention Cardiovascular
    Item
    history of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
    boolean
    C0027051 (UMLS CUI [1])
    C0038454 (UMLS CUI [2])
    C0184661 (UMLS CUI [3,1])
    C3887460 (UMLS CUI [3,2])
    Antiplatelet Agents | Anticoagulants | Plavix | Coumadin
    Item
    patients on anti-platlet drugs or anticoagulants such as placix and coumadin.
    boolean
    C0085826 (UMLS CUI [1])
    C0003280 (UMLS CUI [2])
    C0633084 (UMLS CUI [3])
    C0699129 (UMLS CUI [4])
    CNS metastases Systemic | Stable status Post Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued
    Item
    systemic central nervous system metastases. the patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
    boolean
    C0686377 (UMLS CUI [1,1])
    C0205373 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [2,3])
    C0001617 (UMLS CUI [3,1])
    C1444662 (UMLS CUI [3,2])
    Pregnancy | Breast Feeding
    Item
    pregnant or nursing women.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Erlotinib Refractory Primary
    Item
    patients who are primarily refactory to erlotinib.
    boolean
    C1135135 (UMLS CUI [1,1])
    C0205269 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
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