ID

40920

Description

Randomized Phase 1/2 Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00862082

Link

https://clinicaltrials.gov/show/NCT00862082

Keywords

  1. 6/5/20 6/5/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 5, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT00862082

Eligibility Hepatocellular Carcinoma NCT00862082

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced-stage hepatocellular carcinoma considered non-operable that is suitable for treatment with sorafenib. subjects who have demonstrated progression following initial surgical or locoregional therapy are eligible
Description

Liver carcinoma Advanced Inoperable | Liver carcinoma suitable Sorafenib | Progression Following Operative Surgical Procedure | Progression Following Therapy Locoregional

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205187
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1516119
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332282
UMLS CUI [3,3]
C0543467
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0332282
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C1947913
confirmed hepatocellular carcinoma by pathological analysis (tissue aspirate or biopsy)
Description

Liver carcinoma Tumor tissue sample | Liver carcinoma Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0005558
no previous systemic therapy for hepatocellular carcinoma
Description

Systemic therapy Absent Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2239176
eastern cooperative oncology group (ecog) performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
child-pugh liver function class a
Description

Liver function Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
life expectancy of 12 weeks or more
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate hematologic function [absolute neutrophil count (anc) ≥ 1.5 x 10^9/l; platelet count ≥100×10^9 per liter; hemoglobin ≥8.5 g per deciliter maintained in the absence of red blood cell transfusions; and prothrombin time international normalized ratio ≤1.7; or prothrombin time ≤2 seconds above control]
Description

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Red Blood Cell Transfusion Absent | Prothrombin time international normalized ratio (PT-INR) | Prothrombin time finding

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5,1]
C0086252
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C1821762
UMLS CUI [7]
C1533047
adequate hepatic function (albumin ≥2.8 g per deciliter; total bilirubin ≤2 mg per deciliter [51.3 μmol per liter]; and alanine aminotransferase and aspartate aminotransferase ≤5 times the upper limit of the normal range)
Description

Liver function | Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201838
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
adequate renal function (serum creatinine ≤1.5 times the upper limit of the normal range or creatinine clearance ≥60 ml/min).
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
at least one untreated target lesion that could be measured in one dimension, according to the response evaluation criteria in solid tumors (recist)
Description

Target Lesion Untreated Quantity | Target Lesion Measurable Linear

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C0205132
concomitant systemic antiviral therapy allowed
Description

Antiviral Therapy Systemic allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0683607
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous molecularly targeted therapies or any other systemic treatment for hepatocellular carcinoma
Description

Molecular Targeted Therapy Liver carcinoma | Systemic therapy Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C2699893
UMLS CUI [1,2]
C2239176
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C2239176
active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study
Description

Cancer Other Affecting Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
women who are pregnant, breast-feeding or planning to become pregnant during the study
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication
Description

Females & males of reproductive potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the subject's safety during study participation such as: uncontrolled infection or infection requiring a concomitant parenteral antibiotic; uncontrolled diabetes; congestive heart failure; myocardial infarction within 6 months of study; chronic renal disease; or coagulopathy (excluding prophylactic anticoagulation)
Description

Disease At risk Patient safety | Laboratory finding At risk Patient safety | Communicable Disease Uncontrolled | Communicable Disease Requirement Antibiotics Parenteral | Diabetic - poor control | Congestive heart failure | Myocardial Infarction | Chronic Kidney Diseases | Blood Coagulation Disorders | Exception Prophylaxis Anticoagulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0003232
UMLS CUI [4,4]
C1518896
UMLS CUI [5]
C0421258
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0027051
UMLS CUI [8]
C1561643
UMLS CUI [9]
C0005779
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0199176
UMLS CUI [10,3]
C0003281
active central nervous system metastatic disease requiring intervention
Description

CNS metastases Requirement Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184661
less than four weeks since major surgery
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
known human immunodeficiency virus (hiv) positivity
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699

Similar models

Eligibility Hepatocellular Carcinoma NCT00862082

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma Advanced Inoperable | Liver carcinoma suitable Sorafenib | Progression Following Operative Surgical Procedure | Progression Following Therapy Locoregional
Item
advanced-stage hepatocellular carcinoma considered non-operable that is suitable for treatment with sorafenib. subjects who have demonstrated progression following initial surgical or locoregional therapy are eligible
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1516119 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0332282 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4,1])
C0332282 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C1947913 (UMLS CUI [4,4])
Liver carcinoma Tumor tissue sample | Liver carcinoma Biopsy
Item
confirmed hepatocellular carcinoma by pathological analysis (tissue aspirate or biopsy)
boolean
C2239176 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Systemic therapy Absent Liver carcinoma
Item
no previous systemic therapy for hepatocellular carcinoma
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Liver function Child-Pugh Classification
Item
child-pugh liver function class a
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of 12 weeks or more
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Red Blood Cell Transfusion Absent | Prothrombin time international normalized ratio (PT-INR) | Prothrombin time finding
Item
adequate hematologic function [absolute neutrophil count (anc) ≥ 1.5 x 10^9/l; platelet count ≥100×10^9 per liter; hemoglobin ≥8.5 g per deciliter maintained in the absence of red blood cell transfusions; and prothrombin time international normalized ratio ≤1.7; or prothrombin time ≤2 seconds above control]
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0086252 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1821762 (UMLS CUI [6])
C1533047 (UMLS CUI [7])
Liver function | Albumin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
adequate hepatic function (albumin ≥2.8 g per deciliter; total bilirubin ≤2 mg per deciliter [51.3 μmol per liter]; and alanine aminotransferase and aspartate aminotransferase ≤5 times the upper limit of the normal range)
boolean
C0232741 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
adequate renal function (serum creatinine ≤1.5 times the upper limit of the normal range or creatinine clearance ≥60 ml/min).
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Target Lesion Untreated Quantity | Target Lesion Measurable Linear
Item
at least one untreated target lesion that could be measured in one dimension, according to the response evaluation criteria in solid tumors (recist)
boolean
C2986546 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0205132 (UMLS CUI [2,3])
Antiviral Therapy Systemic allowed
Item
concomitant systemic antiviral therapy allowed
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Molecular Targeted Therapy Liver carcinoma | Systemic therapy Liver carcinoma
Item
previous molecularly targeted therapies or any other systemic treatment for hepatocellular carcinoma
boolean
C2699893 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Cancer Other Affecting Research results
Item
active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study
boolean
C1707251 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, breast-feeding or planning to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Disease At risk Patient safety | Laboratory finding At risk Patient safety | Communicable Disease Uncontrolled | Communicable Disease Requirement Antibiotics Parenteral | Diabetic - poor control | Congestive heart failure | Myocardial Infarction | Chronic Kidney Diseases | Blood Coagulation Disorders | Exception Prophylaxis Anticoagulation
Item
evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the subject's safety during study participation such as: uncontrolled infection or infection requiring a concomitant parenteral antibiotic; uncontrolled diabetes; congestive heart failure; myocardial infarction within 6 months of study; chronic renal disease; or coagulopathy (excluding prophylactic anticoagulation)
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003232 (UMLS CUI [4,3])
C1518896 (UMLS CUI [4,4])
C0421258 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C1561643 (UMLS CUI [8])
C0005779 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0199176 (UMLS CUI [10,2])
C0003281 (UMLS CUI [10,3])
CNS metastases Requirement Intervention
Item
active central nervous system metastatic disease requiring intervention
boolean
C0686377 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Major surgery
Item
less than four weeks since major surgery
boolean
C0679637 (UMLS CUI [1])
HIV Seropositivity
Item
known human immunodeficiency virus (hiv) positivity
boolean
C0019699 (UMLS CUI [1])

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