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ID

15170

Beskrivning

A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor; ODM derived from: https://clinicaltrials.gov/show/NCT02365662

Länk

https://clinicaltrials.gov/show/NCT02365662

Nyckelord

  1. 2016-05-20 2016-05-20 -
Uppladdad den

20 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

    Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    eastern cooperative oncology group (ecog) performance status 0 or 2.
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    has a solid tumor likely to exhibit elevated levels of egfr (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer
    Beskrivning

    Solid tumour | Estimated Glomerular Filtration Rate Level Elevated | Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma | Triple-Negative Breast Cancer Finding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0280100
    UMLS CUI [2,1]
    C3811844
    UMLS CUI [2,2]
    C0441889
    UMLS CUI [2,3]
    C3163633
    UMLS CUI [3]
    C1168401
    UMLS CUI [4]
    C0007131
    UMLS CUI [5]
    C2348819
    ,colorectal carcinoma and glioblastoma multiforme).
    Beskrivning

    Colorectal Carcinoma | Glioblastoma Multiforme

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009402
    UMLS CUI [2]
    C1621958
    has an archived, diagnostic tumor tissue available for analysis.
    Beskrivning

    Tumor tissue sample Diagnostic archived Availability Analysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0348026
    UMLS CUI [1,3]
    C1548398
    UMLS CUI [1,4]
    C0470187
    UMLS CUI [1,5]
    C0936012
    has adequate hematologic, renal, cardiac and hepatic function.
    Beskrivning

    Hematologic function | Renal function | Cardiac function | Liver function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C0232164
    UMLS CUI [4]
    C0232741
    expanded safety cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
    Beskrivning

    Cohort Safety Expanded | Secondary malignant neoplasm of lung | Disease Progression | Prior Chemotherapy Containing Platinum

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0599755
    UMLS CUI [1,2]
    C0036043
    UMLS CUI [1,3]
    C0205229
    UMLS CUI [2]
    C0153676
    UMLS CUI [3]
    C0242656
    UMLS CUI [4,1]
    C1514457
    UMLS CUI [4,2]
    C0332256
    UMLS CUI [4,3]
    C0032207
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previously received an egfr-directed monoclonal antibody within the past 4 weeks.
    Beskrivning

    Monoclonal Antibodies Previous As directed for Estimated Glomerular Filtration Rate

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0003250
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C1720148
    UMLS CUI [1,4]
    C3811844
    has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > grade 1 on common terminology criteria for adverse events.
    Beskrivning

    Cancer treatment Previous Causing Toxic effect | Common Terminology Criteria for Adverse Events

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C0678227
    UMLS CUI [1,4]
    C0600688
    UMLS CUI [2]
    C3888020
    history of major immunologic reaction to any igg containing agent.
    Beskrivning

    Immunologic reaction Major Pharmacologic Substance Containing Immunoglobulin G

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0301873
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [1,3]
    C1254351
    UMLS CUI [1,4]
    C0332256
    UMLS CUI [1,5]
    C0020852
    any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
    Beskrivning

    Medical condition High risk of Toxic effect

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1699700
    UMLS CUI [1,2]
    C0332167
    UMLS CUI [1,3]
    C0600688

    Similar models

    Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status 0 or 2.
    boolean
    C1520224 (UMLS CUI [1])
    Solid tumour | Estimated Glomerular Filtration Rate Level Elevated | Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma | Triple-Negative Breast Cancer Finding
    Item
    has a solid tumor likely to exhibit elevated levels of egfr (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer
    boolean
    C0280100 (UMLS CUI [1])
    C3811844 (UMLS CUI [2,1])
    C0441889 (UMLS CUI [2,2])
    C3163633 (UMLS CUI [2,3])
    C1168401 (UMLS CUI [3])
    C0007131 (UMLS CUI [4])
    C2348819 (UMLS CUI [5])
    Colorectal Carcinoma | Glioblastoma Multiforme
    Item
    ,colorectal carcinoma and glioblastoma multiforme).
    boolean
    C0009402 (UMLS CUI [1])
    C1621958 (UMLS CUI [2])
    Tumor tissue sample Diagnostic archived Availability Analysis
    Item
    has an archived, diagnostic tumor tissue available for analysis.
    boolean
    C0475358 (UMLS CUI [1,1])
    C0348026 (UMLS CUI [1,2])
    C1548398 (UMLS CUI [1,3])
    C0470187 (UMLS CUI [1,4])
    C0936012 (UMLS CUI [1,5])
    Hematologic function | Renal function | Cardiac function | Liver function
    Item
    has adequate hematologic, renal, cardiac and hepatic function.
    boolean
    C0221130 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    C0232164 (UMLS CUI [3])
    C0232741 (UMLS CUI [4])
    Cohort Safety Expanded | Secondary malignant neoplasm of lung | Disease Progression | Prior Chemotherapy Containing Platinum
    Item
    expanded safety cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
    boolean
    C0599755 (UMLS CUI [1,1])
    C0036043 (UMLS CUI [1,2])
    C0205229 (UMLS CUI [1,3])
    C0153676 (UMLS CUI [2])
    C0242656 (UMLS CUI [3])
    C1514457 (UMLS CUI [4,1])
    C0332256 (UMLS CUI [4,2])
    C0032207 (UMLS CUI [4,3])
    Item Group
    C0680251 (UMLS CUI)
    Monoclonal Antibodies Previous As directed for Estimated Glomerular Filtration Rate
    Item
    previously received an egfr-directed monoclonal antibody within the past 4 weeks.
    boolean
    C0003250 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C1720148 (UMLS CUI [1,3])
    C3811844 (UMLS CUI [1,4])
    Cancer treatment Previous Causing Toxic effect | Common Terminology Criteria for Adverse Events
    Item
    has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > grade 1 on common terminology criteria for adverse events.
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C0678227 (UMLS CUI [1,3])
    C0600688 (UMLS CUI [1,4])
    C3888020 (UMLS CUI [2])
    Immunologic reaction Major Pharmacologic Substance Containing Immunoglobulin G
    Item
    history of major immunologic reaction to any igg containing agent.
    boolean
    C0301873 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C1254351 (UMLS CUI [1,3])
    C0332256 (UMLS CUI [1,4])
    C0020852 (UMLS CUI [1,5])
    Medical condition High risk of Toxic effect
    Item
    any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
    boolean
    C1699700 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C0600688 (UMLS CUI [1,3])

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