ID

44416

Beschreibung

Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01003015

Link

https://clinicaltrials.gov/show/NCT01003015

Stichworte

Versionen (2)
  1. 12.11.17 12.11.17 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT01003015

Englisch

Eligibility Carcinoma, Hepatocellular NCT01003015

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged equal or above 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
bclc stage category a, b or c that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
Beschreibung

Hepatocellular Carcinoma by BCLC Stage | Therapeutic procedure Established failed | Excision | Transplantation of liver | Local Ablation Therapy | Chemoembolization | Sorafenib Systemic

Datentyp

boolean

Alias
UMLS CUI [1]
C3898888
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0443211
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0728940
UMLS CUI [4]
C0023911
UMLS CUI [5]
C0547070
UMLS CUI [6]
C0796679
UMLS CUI [7,1]
C1516119
UMLS CUI [7,2]
C0205373
liver function status child-pugh class a.
Beschreibung

Liver function Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
Beschreibung

Sorafenib Therapeutic procedure failed | Disease Progression Radiology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0043299
local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of bay73-4506.
Beschreibung

Local Therapy Completed | Therapeutic procedure Local-Regional Completed | Operative Surgical Procedures | Therapeutic radiology procedure | Arterial embolization Hepatic | Chemoembolization | Radiofrequency ablation | Percutaneous ethanol injection therapy | Cryoablation | BAY 73-4506

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1947913
UMLS CUI [2,3]
C0205197
UMLS CUI [3]
C0543467
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C3163695
UMLS CUI [5,2]
C0205054
UMLS CUI [6]
C0796679
UMLS CUI [7]
C0850292
UMLS CUI [8]
C1535909
UMLS CUI [9]
C0010408
UMLS CUI [10]
C2703114
ecog ps of 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and renal function
Beschreibung

Bone Marrow function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic treatment with molecular targeted agents for hcc, except sorafenib. prior chemotherapy treatment is allowed.
Beschreibung

Systemic therapy | Molecular Targeted Therapy Liver carcinoma | Exception Sorafenib | Prior Chemotherapy allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2,1]
C2699893
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1516119
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0683607
known history or symptomatic metastatic brain or meningeal tumors (head ct or mri at screening to confirm the absence of central nervous system [cns] disease if patient has symptoms suggestive or consistent with cns disease).
Beschreibung

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Symptomatic | Meningeal Carcinomatosis | Meningeal Carcinomatosis Symptomatic | CNS disorder Absent CT head | CNS disorder Absent MRI of head | Symptoms Suggestive of CNS disorder | Symptoms Consistent with CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0220654
UMLS CUI [4,1]
C0220654
UMLS CUI [4,2]
C0231220
UMLS CUI [5,1]
C0007682
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0202691
UMLS CUI [6,1]
C0007682
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0412674
UMLS CUI [7,1]
C1457887
UMLS CUI [7,2]
C0332299
UMLS CUI [7,3]
C0007682
UMLS CUI [8,1]
C1457887
UMLS CUI [8,2]
C0332290
UMLS CUI [8,3]
C0007682
congestive heart failure nyha>/= class 2
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (mi) within the past 6 months before start of study medication.
Beschreibung

Angina, Unstable | Angina symptom At rest | New onset angina | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0858277
UMLS CUI [2,2]
C0443144
UMLS CUI [3]
C0340289
UMLS CUI [4]
C0027051
cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
Beschreibung

Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists allowed | Digoxin allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003195
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0012265
UMLS CUI [3,2]
C0683607
uncontrolled hypertension (systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management).
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Disease Management Optimal

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C2698651
arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
Beschreibung

Thrombotic episodes Arterial | Thrombotic episodes Venous | Embolism Arterial | Embolism Venous | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2674163
UMLS CUI [1,2]
C0221464
UMLS CUI [2,1]
C2674163
UMLS CUI [2,2]
C0348013
UMLS CUI [3,1]
C0013922
UMLS CUI [3,2]
C0221464
UMLS CUI [4,1]
C0013922
UMLS CUI [4,2]
C0348013
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0149871
UMLS CUI [8]
C0034065
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Ähnliche Modelle

Eligibility Carcinoma, Hepatocellular NCT01003015

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged equal or above 18 years.
boolean
C0001779 (UMLS CUI [1])
Hepatocellular Carcinoma by BCLC Stage | Therapeutic procedure Established failed | Excision | Transplantation of liver | Local Ablation Therapy | Chemoembolization | Sorafenib Systemic
Item
bclc stage category a, b or c that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
boolean
C3898888 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3])
C0023911 (UMLS CUI [4])
C0547070 (UMLS CUI [5])
C0796679 (UMLS CUI [6])
C1516119 (UMLS CUI [7,1])
C0205373 (UMLS CUI [7,2])
Liver function Child-Pugh Classification
Item
liver function status child-pugh class a.
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Sorafenib Therapeutic procedure failed | Disease Progression Radiology
Item
failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
boolean
C1516119 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Local Therapy Completed | Therapeutic procedure Local-Regional Completed | Operative Surgical Procedures | Therapeutic radiology procedure | Arterial embolization Hepatic | Chemoembolization | Radiofrequency ablation | Percutaneous ethanol injection therapy | Cryoablation | BAY 73-4506
Item
local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of bay73-4506.
boolean
C1517925 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C3163695 (UMLS CUI [5,1])
C0205054 (UMLS CUI [5,2])
C0796679 (UMLS CUI [6])
C0850292 (UMLS CUI [7])
C1535909 (UMLS CUI [8])
C0010408 (UMLS CUI [9])
C2703114 (UMLS CUI [10])
ECOG performance status
Item
ecog ps of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Systemic therapy | Molecular Targeted Therapy Liver carcinoma | Exception Sorafenib | Prior Chemotherapy allowed
Item
prior systemic treatment with molecular targeted agents for hcc, except sorafenib. prior chemotherapy treatment is allowed.
boolean
C1515119 (UMLS CUI [1])
C2699893 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Symptomatic | Meningeal Carcinomatosis | Meningeal Carcinomatosis Symptomatic | CNS disorder Absent CT head | CNS disorder Absent MRI of head | Symptoms Suggestive of CNS disorder | Symptoms Consistent with CNS disorder
Item
known history or symptomatic metastatic brain or meningeal tumors (head ct or mri at screening to confirm the absence of central nervous system [cns] disease if patient has symptoms suggestive or consistent with cns disease).
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220654 (UMLS CUI [3])
C0220654 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0007682 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0202691 (UMLS CUI [5,3])
C0007682 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0412674 (UMLS CUI [6,3])
C1457887 (UMLS CUI [7,1])
C0332299 (UMLS CUI [7,2])
C0007682 (UMLS CUI [7,3])
C1457887 (UMLS CUI [8,1])
C0332290 (UMLS CUI [8,2])
C0007682 (UMLS CUI [8,3])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure nyha>/= class 2
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable | Angina symptom At rest | New onset angina | Myocardial Infarction
Item
unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (mi) within the past 6 months before start of study medication.
boolean
C0002965 (UMLS CUI [1])
C0858277 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0340289 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists allowed | Digoxin allowed
Item
cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C0304516 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0012265 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Disease Management Optimal
Item
uncontrolled hypertension (systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0376636 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
Thrombotic episodes Arterial | Thrombotic episodes Venous | Embolism Arterial | Embolism Venous | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism
Item
arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
boolean
C2674163 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C2674163 (UMLS CUI [2,1])
C0348013 (UMLS CUI [2,2])
C0013922 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C0013922 (UMLS CUI [4,1])
C0348013 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0149871 (UMLS CUI [7])
C0034065 (UMLS CUI [8])
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