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ID

15170

Description

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

Link

https://clinicaltrials.gov/show/NCT02365662

Keywords

  1. 5/20/16 5/20/16 -
Uploaded on

May 20, 2016

DOI

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License

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
    Description

    Inclusion Criteria

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

    ECOG performance status

    Data type

    boolean

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

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280100 (Solid Neoplasm)
    UMLS CUI [2,1]
    C3811844 (Estimated Glomerular Filtration Rate)
    UMLS CUI [2,2]
    C0441889 (Levels (qualifier value))
    SNOMED
    258395000
    UMLS CUI [2,3]
    C3163633 (Elevated)
    UMLS CUI [3]
    C1168401 (Squamous cell carcinoma of the head and neck)
    SNOMED
    716659002
    UMLS CUI [4]
    C0007131 (Non-Small Cell Lung Carcinoma)
    SNOMED
    254637007
    UMLS CUI [5]
    C2348819 (Triple-Negative Breast Cancer Finding)
    ,colorectal carcinoma and glioblastoma multiforme).
    Description

    Colorectal Carcinoma | Glioblastoma Multiforme

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009402 (Colorectal Carcinoma)
    LOINC
    LA15686-1
    UMLS CUI [2]
    C1621958 (Glioblastoma Multiforme)
    SNOMED
    393563007
    has an archived, diagnostic tumor tissue available for analysis.
    Description

    Tumor tissue sample Diagnostic archived Availability Analysis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358 (Tumor tissue sample)
    SNOMED
    258435002
    UMLS CUI [1,2]
    C0348026 (Diagnostic)
    SNOMED
    261004008
    LOINC
    LP249287-6
    UMLS CUI [1,3]
    C1548398 (archived (not active))
    UMLS CUI [1,4]
    C0470187 (Availability of)
    SNOMED
    103328004
    UMLS CUI [1,5]
    C0936012 (Analysis)
    has adequate hematologic, renal, cardiac and hepatic function.
    Description

    Hematologic function | Renal function | Cardiac function | Liver function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130 (Hematologic function)
    SNOMED
    86084001
    UMLS CUI [2]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [3]
    C0232164 (Cardiac function)
    SNOMED
    86185002
    UMLS CUI [4]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    expanded safety cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0599755 (Cohort)
    UMLS CUI [1,2]
    C0036043 (Safety)
    LOINC
    LA17589-5
    UMLS CUI [1,3]
    C0205229 (Expanding)
    SNOMED
    70955005
    LOINC
    LA26029-1
    UMLS CUI [2]
    C0153676 (Secondary malignant neoplasm of lung)
    SNOMED
    94391008
    UMLS CUI [3]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI [4,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [4,2]
    C0332256 (Containing (qualifier))
    SNOMED
    42504009
    UMLS CUI [4,3]
    C0032207 (platinum)
    SNOMED
    84847000
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    previously received an egfr-directed monoclonal antibody within the past 4 weeks.
    Description

    Monoclonal Antibodies Previous As directed for Estimated Glomerular Filtration Rate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003250 (Monoclonal Antibodies)
    SNOMED
    108807002
    UMLS CUI [1,2]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI [1,3]
    C1720148 (As directed for)
    SNOMED
    422135004
    UMLS CUI [1,4]
    C3811844 (Estimated Glomerular Filtration Rate)
    has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > grade 1 on common terminology criteria for adverse events.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425 (cancer treatment)
    UMLS CUI [1,2]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI [1,3]
    C0678227 (Causing)
    SNOMED
    23981006
    UMLS CUI [1,4]
    C0600688 (Toxic effect)
    SNOMED
    75478009
    UMLS CUI [2]
    C3888020 (Common Terminology Criteria for Adverse Events)
    history of major immunologic reaction to any igg containing agent.
    Description

    Immunologic reaction Major Pharmacologic Substance Containing Immunoglobulin G

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0301873 (Immunologic reaction)
    SNOMED
    56393004
    UMLS CUI [1,2]
    C0205164 (Major)
    SNOMED
    255603008
    LOINC
    LA29634-5
    UMLS CUI [1,3]
    C1254351 (Pharmacologic Substance)
    LOINC
    LP172750-4
    UMLS CUI [1,4]
    C0332256 (Containing (qualifier))
    SNOMED
    42504009
    UMLS CUI [1,5]
    C0020852 (immunoglobulin G)
    SNOMED
    29246005
    LOINC
    LP14672-7
    any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
    Description

    Medical condition High risk of Toxic effect

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1699700 (medical condition category)
    UMLS CUI [1,2]
    C0332167 (High risk of)
    SNOMED
    15508007
    UMLS CUI [1,3]
    C0600688 (Toxic effect)
    SNOMED
    75478009

    Similar models

    Eligibility Head and Neck Squamous Cell Carcinoma NCT02365662

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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