ID

21002

Beskrivning

SU011248 in Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00361309

Länk

https://clinicaltrials.gov/show/NCT00361309

Nyckelord

  1. 2017-04-03 2017-04-03 -
Uppladdad den

3 april 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT00361309

Eligibility Hepatocellular Carcinoma NCT00361309

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed hcc and should have metastatic or locally advanced unresectable disease
Beskrivning

Liver carcinoma | Disease unresectable metastatic | Disease unresectable Advanced Local

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C1522484
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1519810
UMLS CUI [3,3]
C0205179
UMLS CUI [3,4]
C0205276
measurable disease
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
0-1 prior systemic chemotherapy regimens for hcc
Beskrivning

Systemic Chemotherapy Quantity Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2239176
age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and marrow function
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
women of child-bearing potential must have a negative pregnancy test prior to study entry
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy, radiotherapy or major surgery within 4 weeks of study entry
Beskrivning

Chemotherapy | Therapeutic radiology procedure | major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0679637
receiving any other investigational agents within past 30 days
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
known brain metastases
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
clip score > 3
Beskrivning

Liver carcinoma Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0449820
chronic diarrhea or any disorder that will limit adequate absorption of su011248
Beskrivning

Chronic diarrhea | Disease Limiting SU 11248 Absorption

Datatyp

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C1176021
UMLS CUI [2,4]
C0237442
prolongation of qtc > 450 msec in screening electrocardiogram or history of familial long qt syndrome
Beskrivning

Electrocardiogram QT corrected interval prolonged | Prolonged QTc Family history

Datatyp

boolean

Alias
UMLS CUI [1]
C0855333
UMLS CUI [2,1]
C1969409
UMLS CUI [2,2]
C0241889
uncontrolled intercurrent illness
Beskrivning

Comorbidity Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
greater than or equal to 2g of protein/24hr
Beskrivning

Protein g/24h

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0202202
UMLS CUI [1,2]
C0439417

Similar models

Eligibility Hepatocellular Carcinoma NCT00361309

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Disease unresectable metastatic | Disease unresectable Advanced Local
Item
histologically or cytologically confirmed hcc and should have metastatic or locally advanced unresectable disease
boolean
C2239176 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C0205276 (UMLS CUI [3,4])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Systemic Chemotherapy Quantity Liver carcinoma
Item
0-1 prior systemic chemotherapy regimens for hcc
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative
Item
women of child-bearing potential must have a negative pregnancy test prior to study entry
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | major surgery
Item
chemotherapy, radiotherapy or major surgery within 4 weeks of study entry
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Investigational New Drugs
Item
receiving any other investigational agents within past 30 days
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Liver carcinoma Score
Item
clip score > 3
boolean
C2239176 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Chronic diarrhea | Disease Limiting SU 11248 Absorption
Item
chronic diarrhea or any disorder that will limit adequate absorption of su011248
boolean
C0401151 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1176021 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
Electrocardiogram QT corrected interval prolonged | Prolonged QTc Family history
Item
prolongation of qtc > 450 msec in screening electrocardiogram or history of familial long qt syndrome
boolean
C0855333 (UMLS CUI [1])
C1969409 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Protein g/24h
Item
greater than or equal to 2g of protein/24hr
boolean
C0202202 (UMLS CUI [1,1])
C0439417 (UMLS CUI [1,2])

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