ID

38378

Beschreibung

Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT01204177

Link

https://clinicaltrials.gov/show/NCT01204177

Stichworte

Versionen (2)
  1. 14.10.19 14.10.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. Oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT01204177

Englisch

Eligibility Carcinoma, Hepatocellular NCT01204177

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female age >/= 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy >/= 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
histologically or cytologically confirmed diagnosis of hcc, unresectable advanced or metastatic
Beschreibung

Liver cell carcinoma non-resectable Advanced | Metastatic hepatocellular carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1112459
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0744869
liver function status of child-pugh class a. child-pugh status based on clinical findings and laboratory results during the screening period
Beschreibung

Liver function Clinical findings Child-Pugh Classification | Liver function Laboratory Results Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C2347612
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1254595
UMLS CUI [2,3]
C2347612
eastern cooperative oncology group performance status (ecog ps) of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by ct or mri according to recist 1.1
Beschreibung

Measurable lesion Linear Quantity | CT | MRI | Therapy naive Locoregional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
UMLS CUI [4,1]
C0919936
UMLS CUI [4,2]
C1947913
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
previous or concurrent cancer other than hcc, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
Beschreibung

Malignant Neoplasms | Exception Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1336527
history of cardiac disease: congestive heart failure (chf), unstable angina, arrhythmias, uncontrolled hypertension
Beschreibung

Heart Disease | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0003811
UMLS CUI [5]
C1868885
clinically significant gi bleeding (ctcae grade 3 or higher) within 30 days
Beschreibung

Gastrointestinal Hemorrhage CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C1516728
renal failure requiring hemo- or peritoneal dialysis
Beschreibung

Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0031139
known human immunodeficiency virus (hiv) infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
known history or symptomatic metastatic brain or meningeal tumors
Beschreibung

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C1704231
UMLS CUI [4,2]
C0231220
history of organ allograft.
Beschreibung

Organ Allograft

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
history of interstitial lung disease (ild).
Beschreibung

Lung Disease, Interstitial

Datentyp

boolean

Alias
UMLS CUI [1]
C0206062
excluded previous therapies and medications:
Beschreibung

Prior Therapy Excluded | Pharmaceutical Preparations Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332196
prior use of systemic anti-cancer treatment for hcc including cytotoxic chemotherapy, targeted agents, or any experimental therapy
Beschreibung

Cancer treatment Systemic Liver carcinoma | Cytotoxic Chemotherapy | Pharmaceutical Preparations Targeted | Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C2239176
UMLS CUI [2]
C0677881
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1521840
UMLS CUI [4]
C0949266
radiotherapy within 4 weeks prior to start of study treatment
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
any other investigational agents within 4 weeks from the first dose of study treatment
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
major surgery within 4 weeks of start of study
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
concomitant use of strong inhibitors and strong inducers of cyp3a4
Beschreibung

CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
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Ähnliche Modelle

Eligibility Carcinoma, Hepatocellular NCT01204177

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female age >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >/= 12 weeks
boolean
C0023671 (UMLS CUI [1])
Liver cell carcinoma non-resectable Advanced | Metastatic hepatocellular carcinoma
Item
histologically or cytologically confirmed diagnosis of hcc, unresectable advanced or metastatic
boolean
C1112459 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0744869 (UMLS CUI [2])
Liver function Clinical findings Child-Pugh Classification | Liver function Laboratory Results Child-Pugh Classification
Item
liver function status of child-pugh class a. child-pugh status based on clinical findings and laboratory results during the screening period
boolean
C0232741 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C1254595 (UMLS CUI [2,2])
C2347612 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group performance status (ecog ps) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Linear Quantity | CT | MRI | Therapy naive Locoregional
Item
patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by ct or mri according to recist 1.1
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0919936 (UMLS CUI [4,1])
C1947913 (UMLS CUI [4,2])
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)
Malignant Neoplasms | Exception Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder
Item
previous or concurrent cancer other than hcc, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1336527 (UMLS CUI [5,2])
Heart Disease | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Uncontrolled hypertension
Item
history of cardiac disease: congestive heart failure (chf), unstable angina, arrhythmias, uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
Gastrointestinal Hemorrhage CTCAE Grades
Item
clinically significant gi bleeding (ctcae grade 3 or higher) within 30 days
boolean
C0017181 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis
Item
renal failure requiring hemo- or peritoneal dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0031139 (UMLS CUI [2,3])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic
Item
known history or symptomatic metastatic brain or meningeal tumors
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C0220650 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1704231 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Organ Allograft
Item
history of organ allograft.
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Lung Disease, Interstitial
Item
history of interstitial lung disease (ild).
boolean
C0206062 (UMLS CUI [1])
Prior Therapy Excluded | Pharmaceutical Preparations Excluded
Item
excluded previous therapies and medications:
boolean
C1514463 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Cancer treatment Systemic Liver carcinoma | Cytotoxic Chemotherapy | Pharmaceutical Preparations Targeted | Therapy, Investigational
Item
prior use of systemic anti-cancer treatment for hcc including cytotoxic chemotherapy, targeted agents, or any experimental therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4])
Therapeutic radiology procedure
Item
radiotherapy within 4 weeks prior to start of study treatment
boolean
C1522449 (UMLS CUI [1])
Investigational New Drugs
Item
any other investigational agents within 4 weeks from the first dose of study treatment
boolean
C0013230 (UMLS CUI [1])
Major surgery
Item
major surgery within 4 weeks of start of study
boolean
C0679637 (UMLS CUI [1])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
concomitant use of strong inhibitors and strong inducers of cyp3a4
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
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