ID

30246

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00791544

Nyckelord

Versioner (2)
  1. 2018-05-24 2018-05-24 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Liver Carcinoma NCT00791544

Engelsk

Eligibility Liver Carcinoma NCT00791544

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1512714
UMLS CUI [2,3]
C0023911
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1512714
UMLS CUI [3,3]
C0547070
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1512714
UMLS CUI [4,3]
C0796679
UMLS CUI [5]
C2239176
UMLS CUI [6,1]
C0023903
UMLS CUI [6,2]
C1512560
UMLS CUI [7,1]
C0015950
UMLS CUI [7,2]
C0441889
signed and dated approved patient informed consent form prior to enrollment into the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
ecog performance status > 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
inadequate organ function:
Beskrivning

Organ function Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
neutrophils (anc) < 1,500/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin < 10g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
platelets < 100,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin > 1.5 x uln
Beskrivning

Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
asat, alat > 3 x uln
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
creatininemia > 1.5 x uln (or ≥ 2.0 mg/dl)
Beskrivning

Blood creatinine increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0235431
inr > 1.6
Beskrivning

INR raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0853225
liver cirrhosis child pugh b or c (score > 6)
Beskrivning

Liver Cirrhosis Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C2347612
hba1c > 8%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
no measurable or evaluable tumoral lesion
Beskrivning

Absence Tumor Measurable lesion | Absence Tumor Lesion Evaluable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C0221198
UMLS CUI [2,4]
C1516986
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
Beskrivning

Patient Ineligible Sorafenib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C1516119
prior exposure to an anti-igf-1r class compound
Beskrivning

Exposure to IGF-1R Antibody Compound

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4044495
UMLS CUI [1,3]
C0003241
UMLS CUI [1,4]
C1706082
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status | Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1524062
Tillbaka till toppen

Similar models

Eligibility Liver Carcinoma NCT00791544

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
C2347612 (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])
Tillbaka till toppen 

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