ID

30246

Description

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

Keywords

Versions (2)
  1. 5/24/18 5/24/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 24, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Liver Carcinoma NCT00791544

English

Eligibility Liver Carcinoma NCT00791544

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ecog performance status > 2
Description

ECOG performance status

Data type

boolean

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

Organ function Inadequate

Data type

boolean

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

Absolute neutrophil count

Data type

boolean

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

Hemoglobin measurement

Data type

boolean

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

Platelet Count measurement

Data type

boolean

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

Elevated total bilirubin

Data type

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

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

Blood creatinine increased

Data type

boolean

Alias
UMLS CUI [1]
C0235431
inr > 1.6
Description

INR raised

Data type

boolean

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

Liver Cirrhosis Child-Pugh Classification

Data type

boolean

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

Hemoglobin A1c measurement

Data type

boolean

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

Absence Tumor Measurable lesion | Absence Tumor Lesion Evaluable

Data type

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
Description

Patient Ineligible Sorafenib

Data type

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
Description

Exposure to IGF-1R Antibody Compound

Data type

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.
Description

Study Subject Participation Status | Criteria Additional

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Liver Carcinoma NCT00791544

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