0 Beoordelingen
ID

44319

Beschrijving

Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00791544

Link

https://clinicaltrials.gov/show/NCT00791544

Trefwoorden

Versies (2)
  1. 2018-05-24 2018-05-24 -
  2. 2021-09-20 2021-09-20 -
Houder van rechten

See clinicaltrials.gov

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20 september 2021

DOI

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Creative Commons BY 4.0
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    Eligibility Liver Carcinoma NCT00791544

    Engels

    Eligibility Liver Carcinoma NCT00791544

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients not eligible for surgical resection, liver transplantation, local ablation techniques or chemoembolisation and with histologically proven liver carcinoma whenever possible or combination of radiologically documented hypervascular liver tumour and α foeto protein level ≥ 400 ng/ml
    Beschrijving

    Patients Ineligible Excision | Patients Ineligible Transplantation of liver | Patients Ineligible Local Ablation Therapy | Patients Ineligible Chemoembolization | Liver carcinoma | Liver tumor hypervascular | Foetoprotein Level

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C1512714 (Ineligibility)
    UMLS CUI [1,3]
    C0728940 (Excision)
    SNOMED
    65801008
    LOINC
    LA17736-2
    UMLS CUI [2,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [2,2]
    C1512714 (Ineligibility)
    UMLS CUI [2,3]
    C0023911 (Transplantation of liver)
    SNOMED
    18027006
    UMLS CUI [3,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [3,2]
    C1512714 (Ineligibility)
    UMLS CUI [3,3]
    C0547070 (Ablation)
    SNOMED
    257729003
    LOINC
    LP200038-0
    UMLS CUI [4,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [4,2]
    C1512714 (Ineligibility)
    UMLS CUI [4,3]
    C0796679 (Chemoembolization)
    LOINC
    LP266958-0
    UMLS CUI [5]
    C2239176 (Liver carcinoma)
    SNOMED
    109841003
    UMLS CUI [6,1]
    C0023903 (Liver neoplasms)
    SNOMED
    126851005
    UMLS CUI [6,2]
    C1512560 (Hypervascular)
    UMLS CUI [7,1]
    C0015950 (Fetal Proteins)
    SNOMED
    16236008
    LOINC
    LP21015-0
    UMLS CUI [7,2]
    C0441889 (Levels (qualifier value))
    SNOMED
    258395000
    signed and dated approved patient informed consent form prior to enrollment into the study
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    ecog performance status > 2
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    inadequate organ function:
    Beschrijving

    Organ function Inadequate

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0678852 (body system or organ function)
    UMLS CUI [1,2]
    C0205412 (Inadequate (qualifier))
    SNOMED
    71978007
    LOINC
    LA8914-9
    neutrophils (anc) < 1,500/mm3
    Beschrijving

    Absolute neutrophil count

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    hemoglobin < 10g/dl
    Beschrijving

    Hemoglobin measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    platelets < 100,000/mm3
    Beschrijving

    Platelet Count measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    total bilirubin > 1.5 x uln
    Beschrijving

    Elevated total bilirubin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0741494 (Elevated total bilirubin)
    SNOMED
    176271000119108
    asat, alat > 3 x uln
    Beschrijving

    Aspartate aminotransferase increased | Alanine aminotransferase increased

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151904 (Aspartate Aminotransferase Increased)
    UMLS CUI [2]
    C0151905 (Alanine Aminotransferase Increased)
    creatininemia > 1.5 x uln (or ≥ 2.0 mg/dl)
    Beschrijving

    Blood creatinine increased

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0235431 (Blood creatinine increased)
    inr > 1.6
    Beschrijving

    INR raised

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0853225 (INR Increased)
    SNOMED
    313341008
    liver cirrhosis child pugh b or c (score > 6)
    Beschrijving

    Liver Cirrhosis Child-Pugh Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023890 (Liver Cirrhosis)
    SNOMED
    19943007
    UMLS CUI [1,2]
    C4050412 (Child-Pugh Clinical Classification)
    SNOMED
    3191000175106
    hba1c > 8%
    Beschrijving

    Hemoglobin A1c measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0474680 (Hemoglobin A1c measurement)
    SNOMED
    43396009
    no measurable or evaluable tumoral lesion
    Beschrijving

    Absence Tumor Measurable lesion | Absence Tumor Lesion Evaluable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [1,2]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    UMLS CUI [1,3]
    C1513041 (Measurable Disease)
    UMLS CUI [2,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,2]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    UMLS CUI [2,3]
    C0221198 (Lesion)
    SNOMED
    52988006
    UMLS CUI [2,4]
    C1516986 (Evaluable Disease)
    patients not eligible for sorafenib therapy and for whom this therapy cannot be postponed by 3 weeks (during ave1642 single treatment period) in dose escalation part
    Beschrijving

    Patient Ineligible Sorafenib

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C1512714 (Ineligibility)
    UMLS CUI [1,3]
    C1516119 (sorafenib)
    SNOMED
    422042001
    prior exposure to an anti-igf-1r class compound
    Beschrijving

    Exposure to IGF-1R Antibody Compound

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [1,2]
    C4044495 (IGF1R protein, human)
    UMLS CUI [1,3]
    C0003241 (Antibodies)
    SNOMED
    768606008
    LOINC
    LP20667-9
    UMLS CUI [1,4]
    C1706082 (Compound (substance))
    the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    Beschrijving

    Study Subject Participation Status | Criteria Additional

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,1]
    C0243161 (criteria)
    UMLS CUI [2,2]
    C1524062 (Additional)
    LOINC
    LP35025-3
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    Similar models

    Eligibility Liver Carcinoma NCT00791544

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Patients Ineligible Excision | Patients Ineligible Transplantation of liver | Patients Ineligible Local Ablation Therapy | Patients Ineligible Chemoembolization | Liver carcinoma | Liver tumor hypervascular | Foetoprotein Level
    Item
    patients not eligible for surgical resection, liver transplantation, local ablation techniques or chemoembolisation and with histologically proven liver carcinoma whenever possible or combination of radiologically documented hypervascular liver tumour and α foeto protein level ≥ 400 ng/ml
    boolean
    C0030705 (UMLS CUI [1,1])
    C1512714 (UMLS CUI [1,2])
    C0728940 (UMLS CUI [1,3])
    C0030705 (UMLS CUI [2,1])
    C1512714 (UMLS CUI [2,2])
    C0023911 (UMLS CUI [2,3])
    C0030705 (UMLS CUI [3,1])
    C1512714 (UMLS CUI [3,2])
    C0547070 (UMLS CUI [3,3])
    C0030705 (UMLS CUI [4,1])
    C1512714 (UMLS CUI [4,2])
    C0796679 (UMLS CUI [4,3])
    C2239176 (UMLS CUI [5])
    C0023903 (UMLS CUI [6,1])
    C1512560 (UMLS CUI [6,2])
    C0015950 (UMLS CUI [7,1])
    C0441889 (UMLS CUI [7,2])
    Informed Consent
    Item
    signed and dated approved patient informed consent form prior to enrollment into the study
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    ECOG performance status
    Item
    ecog performance status > 2
    boolean
    C1520224 (UMLS CUI [1])
    Organ function Inadequate
    Item
    inadequate organ function:
    boolean
    C0678852 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    Absolute neutrophil count
    Item
    neutrophils (anc) < 1,500/mm3
    boolean
    C0948762 (UMLS CUI [1])
    Hemoglobin measurement
    Item
    hemoglobin < 10g/dl
    boolean
    C0518015 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelets < 100,000/mm3
    boolean
    C0032181 (UMLS CUI [1])
    Elevated total bilirubin
    Item
    total bilirubin > 1.5 x uln
    boolean
    C0741494 (UMLS CUI [1])
    Aspartate aminotransferase increased | Alanine aminotransferase increased
    Item
    asat, alat > 3 x uln
    boolean
    C0151904 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Blood creatinine increased
    Item
    creatininemia > 1.5 x uln (or ≥ 2.0 mg/dl)
    boolean
    C0235431 (UMLS CUI [1])
    INR raised
    Item
    inr > 1.6
    boolean
    C0853225 (UMLS CUI [1])
    Liver Cirrhosis Child-Pugh Classification
    Item
    liver cirrhosis child pugh b or c (score > 6)
    boolean
    C0023890 (UMLS CUI [1,1])
    C4050412 (UMLS CUI [1,2])
    Hemoglobin A1c measurement
    Item
    hba1c > 8%
    boolean
    C0474680 (UMLS CUI [1])
    Absence Tumor Measurable lesion | Absence Tumor Lesion Evaluable
    Item
    no measurable or evaluable tumoral lesion
    boolean
    C0332197 (UMLS CUI [1,1])
    C0027651 (UMLS CUI [1,2])
    C1513041 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [2,1])
    C0027651 (UMLS CUI [2,2])
    C0221198 (UMLS CUI [2,3])
    C1516986 (UMLS CUI [2,4])
    Patient Ineligible Sorafenib
    Item
    patients not eligible for sorafenib therapy and for whom this therapy cannot be postponed by 3 weeks (during ave1642 single treatment period) in dose escalation part
    boolean
    C0030705 (UMLS CUI [1,1])
    C1512714 (UMLS CUI [1,2])
    C1516119 (UMLS CUI [1,3])
    Exposure to IGF-1R Antibody Compound
    Item
    prior exposure to an anti-igf-1r class compound
    boolean
    C0332157 (UMLS CUI [1,1])
    C4044495 (UMLS CUI [1,2])
    C0003241 (UMLS CUI [1,3])
    C1706082 (UMLS CUI [1,4])
    Study Subject Participation Status | Criteria Additional
    Item
    the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    boolean
    C2348568 (UMLS CUI [1])
    C0243161 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
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