0 Ratings

ID

17290

Description

Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01737827

Link

https://clinicaltrials.gov/show/NCT01737827

Keywords

  1. 9/4/16 9/4/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 4, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

    Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    confirmed c-met pathway dysregulation
    Description

    confirmed c-met pathway dysregulation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1456828
    UMLS CUI [1,2]
    C1836729
    advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
    Description

    hepatocellular carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    measurable disease as determined by recist version
    Description

    measurable disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    current cirrhotic status of child-pugh class a with no encephalopathy
    Description

    child-pugh class a

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347612
    eastern cooperative oncology group (ecog) performance status < or = 2.
    Description

    ecog

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    other protocol-defined inclusion criteria may apply.
    Description

    inclusion criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
    Description

    systemic chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1883256
    previous treatment with c-met inhibitor or hepatocyte growth factor targeting therapy.
    Description

    c-met inhibitor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2697591
    previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
    Description

    local therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1517925
    known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
    Description

    active bleeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019080
    clinically significant venous or arterial thrombotic disease within past 6 months.
    Description

    venous or arterial thrombotic disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4049573
    history of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
    Description

    acute or chronic pancreatitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262417
    other protocol-defined exclusion criteria may apply.
    Description

    exclusion criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251

    Similar models

    Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    confirmed c-met pathway dysregulation
    Item
    confirmed c-met pathway dysregulation
    boolean
    C1456828 (UMLS CUI [1,1])
    C1836729 (UMLS CUI [1,2])
    hepatocellular carcinoma
    Item
    advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
    boolean
    C2239176 (UMLS CUI [1])
    measurable disease
    Item
    measurable disease as determined by recist version
    boolean
    C1513041 (UMLS CUI [1])
    child-pugh class a
    Item
    current cirrhotic status of child-pugh class a with no encephalopathy
    boolean
    C2347612 (UMLS CUI [1])
    ecog
    Item
    eastern cooperative oncology group (ecog) performance status < or = 2.
    boolean
    C1520224 (UMLS CUI [1])
    inclusion criteria
    Item
    other protocol-defined inclusion criteria may apply.
    boolean
    C1512693 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    systemic chemotherapy
    Item
    received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
    boolean
    C1883256 (UMLS CUI [1])
    c-met inhibitor
    Item
    previous treatment with c-met inhibitor or hepatocyte growth factor targeting therapy.
    boolean
    C2697591 (UMLS CUI [1])
    local therapy
    Item
    previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
    boolean
    C1517925 (UMLS CUI [1])
    active bleeding
    Item
    known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
    boolean
    C0019080 (UMLS CUI [1])
    venous or arterial thrombotic disease
    Item
    clinically significant venous or arterial thrombotic disease within past 6 months.
    boolean
    C4049573 (UMLS CUI [1])
    acute or chronic pancreatitis
    Item
    history of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
    boolean
    C0262417 (UMLS CUI [1])
    exclusion criteria
    Item
    other protocol-defined exclusion criteria may apply.
    boolean
    C0680251 (UMLS CUI [1])

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