0 Avaliações
ID

13603

Descrição

Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00510939

Link

https://clinicaltrials.gov/show/NCT00510939

Palavras-chave

Versões (1)
  1. 19/02/2016 19/02/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

19 de fevereiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia NCT00510939

    Inglês

    Eligibility Acute Myeloid Leukemia NCT00510939

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. provision of written informed consent
    Descrição

    1. provision of written informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy
    Descrição

    2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0023467
    UMLS CUI [2,2]
    C1518321
    UMLS CUI [3,1]
    C0392920
    UMLS CUI [3,2]
    C3841806
    3. male or female with acute myeloid leukemia in first relapse ( > 60 years)
    Descrição

    3. male or female with acute myeloid leukemia in first relapse ( > 60 years)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0035020
    UMLS CUI [2]
    C0001779
    4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy
    Descrição

    4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    UMLS CUI [2]
    C0392920
    5. negative pregnancy test or evidence of post-menopausal status for female patients.
    Descrição

    negative pregnancy test or evidence of post-menopausal status for female patients.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0232970
    6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)
    Descrição

    6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1419283
    UMLS CUI [2]
    C1423885
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. serum bilirubin 2 x> upper limit of normal (uln)
    Descrição

    1. serum bilirubin 2 x> upper limit of normal (uln)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln
    Descrição

    2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)
    Descrição

    3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    4. patients with aml of fab m3 classification (apl)
    Descrição

    4. patients with aml of fab m3 classification (apl)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission
    Descrição

    5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    6. any clinically defined central nervous system aml.
    Descrição

    6. any clinically defined central nervous system aml.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    UMLS CUI [2]
    C0023467
    7. participation in an investigational drug study within the 30 days prior to entry
    Descrição

    7. participation in an investigational drug study within the 30 days prior to entry

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    8. evidence of uncontrolled infection or cns-hemorrhagic
    Descrição

    8. evidence of uncontrolled infection or cns-hemorrhagic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    9. patients with documented cases of human immunodeficiency virus (hiv)
    Descrição

    9. patients with documented cases of human immunodeficiency virus (hiv)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    10. peripheral neuropathy or neuropathic pain grade > or = 2
    Descrição

    10. peripheral neuropathy or neuropathic pain grade > or = 2

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0031117
    UMLS CUI [2]
    C0458960
    11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
    Descrição

    11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0006030
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0024730
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0019134
    12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
    Descrição

    12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)
    Descrição

    13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1419283
    UMLS CUI [2]
    C1423885
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT00510939

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    written informed consent
    Item
    1. provision of written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    age, aml, unfit for conventional chemotherapy
    Item
    2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy
    boolean
    C0001779 (UMLS CUI [1])
    C0023467 (UMLS CUI [2,1])
    C1518321 (UMLS CUI [2,2])
    C0392920 (UMLS CUI [3,1])
    C3841806 (UMLS CUI [3,2])
    aml in first relapse
    Item
    3. male or female with acute myeloid leukemia in first relapse ( > 60 years)
    boolean
    C0023467 (UMLS CUI [1,1])
    C0035020 (UMLS CUI [1,2])
    C0001779 (UMLS CUI [2])
    who performance status
    Item
    4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy
    boolean
    C1298650 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    negative pregnancy test or evidence of post-menopausal status for female patients.
    Item
    5. negative pregnancy test or evidence of post-menopausal status for female patients.
    boolean
    C0032961 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    rasgrp1/aptx gene expression ratio
    Item
    6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)
    boolean
    C1419283 (UMLS CUI [1])
    C1423885 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    serum bilirubin
    Item
    1. serum bilirubin 2 x> upper limit of normal (uln)
    boolean
    C1278039 (UMLS CUI [1])
    ast and alt
    Item
    2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    creatinine and creatinine clearance
    Item
    3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    apl
    Item
    4. patients with aml of fab m3 classification (apl)
    boolean
    C0023487 (UMLS CUI [1])
    malignancy
    Item
    5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission
    boolean
    C0006826 (UMLS CUI [1])
    central nervous system aml
    Item
    6. any clinically defined central nervous system aml.
    boolean
    C1332884 (UMLS CUI [1])
    C0023467 (UMLS CUI [2])
    participation status
    Item
    7. participation in an investigational drug study within the 30 days prior to entry
    boolean
    C2348568 (UMLS CUI [1])
    uncontrolled infection or cns-hemorrhagic
    Item
    8. evidence of uncontrolled infection or cns-hemorrhagic
    boolean
    C0009488 (UMLS CUI [1])
    hiv
    Item
    9. patients with documented cases of human immunodeficiency virus (hiv)
    boolean
    C0019682 (UMLS CUI [1])
    peripheral neuropathy or neuropathic pain
    Item
    10. peripheral neuropathy or neuropathic pain grade > or = 2
    boolean
    C0031117 (UMLS CUI [1])
    C0458960 (UMLS CUI [2])
    hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
    Item
    11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
    boolean
    C0020517 (UMLS CUI [1,1])
    C0006030 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0024730 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0019134 (UMLS CUI [3,2])
    cardiac disease
    Item
    12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
    boolean
    C0018799 (UMLS CUI [1])
    rasgrp1/aptx gene expression ratio
    Item
    13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)
    boolean
    C1419283 (UMLS CUI [1])
    C1423885 (UMLS CUI [2])
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