0 Ratings
ID

12213

Description

Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02143622

Link

https://clinicaltrials.gov/show/NCT02143622

Keywords

Versions (1)
  1. 10/18/15 10/18/15 -
Uploaded on

October 18, 2015

DOI

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License

Creative Commons BY 4.0
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    Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

    English

    Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    most recent regimen contains both platinum and cetuximab (phase ii, group b).
    Description

    cetuximab; platinum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0995188 (cetuximab)
    SNOMED
    409401002
    UMLS CUI [2]
    C0032207 (platinum)
    SNOMED
    84847000
    ecog performance status (ps) ≤ 2.
    Description

    ecog performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    recovery from all aes of previous anti-cancer therapies, to baseline or to ctcae grade ≤ 1, except for alopecia.
    Description

    Antineoplastic Drug/Agent Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2346834 (Antineoplastic Drug/Agent Therapy)
    measurable disease as determined by recist v1.1.
    Description

    measurable disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    previous anti-her3 antibody treatment.
    Description

    treatment specific antibody

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0443640 (Specific antibody)
    SNOMED
    404263002
    symptomatic brain metastasis.
    Description

    symptomatic; metastasis; brain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0231220 (Symptomatic)
    SNOMED
    264931009
    LOINC
    LA17766-9
    UMLS CUI [2]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [3]
    C0006104 (Brain)
    SNOMED
    12738006
    LOINC
    LP7084-9
    prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
    Description

    cancer treatment; systemic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425 (cancer treatment)
    UMLS CUI [2]
    C0205373 (Systemic)
    SNOMED
    31099001
    prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
    Description

    allergy human immunoglobulin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C3537193 (Human Immunoglobulin [EPC])
    inadequate end organ function.
    Description

    Organ or Tissue Function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1254358 (Organ or Tissue Function)
    ongoing diarrhea ctcae grade ≥ 2. other protocol-defined inclusion/exclusion criteria may apply
    Description

    diarrhea

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011991 (Diarrhea)
    SNOMED
    62315008
    LOINC
    MTHU013347
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    Similar models

    Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    cetuximab; platinum
    Item
    most recent regimen contains both platinum and cetuximab (phase ii, group b).
    boolean
    C0995188 (UMLS CUI [1])
    C0032207 (UMLS CUI [2])
    ecog performance status
    Item
    ecog performance status (ps) ≤ 2.
    boolean
    C1520224 (UMLS CUI [1])
    Antineoplastic Drug/Agent Therapy
    Item
    recovery from all aes of previous anti-cancer therapies, to baseline or to ctcae grade ≤ 1, except for alopecia.
    boolean
    C2346834 (UMLS CUI [1])
    measurable disease
    Item
    measurable disease as determined by recist v1.1.
    boolean
    C1513041 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    treatment specific antibody
    Item
    previous anti-her3 antibody treatment.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0443640 (UMLS CUI [1,2])
    symptomatic; metastasis; brain
    Item
    symptomatic brain metastasis.
    boolean
    C0231220 (UMLS CUI [1])
    C0027627 (UMLS CUI [2])
    C0006104 (UMLS CUI [3])
    cancer treatment; systemic
    Item
    prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
    boolean
    C0920425 (UMLS CUI [1])
    C0205373 (UMLS CUI [2])
    allergy human immunoglobulin
    Item
    prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
    boolean
    C0020517 (UMLS CUI [1,1])
    C3537193 (UMLS CUI [1,2])
    Organ or Tissue Function
    Item
    inadequate end organ function.
    boolean
    C1254358 (UMLS CUI [1])
    diarrhea
    Item
    ongoing diarrhea ctcae grade ≥ 2. other protocol-defined inclusion/exclusion criteria may apply
    boolean
    C0011991 (UMLS CUI [1])
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