ID

21002

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00361309

Palabras clave

Versiones (1)
  1. 3/4/17 3/4/17 -
Subido en

3 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00361309

Inglés

Eligibility Hepatocellular Carcinoma NCT00361309

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Liver carcinoma | Disease unresectable metastatic | Disease unresectable Advanced Local

Tipo de datos

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
Descripción

Measurable Disease

Tipo de datos

boolean

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

Systemic Chemotherapy Quantity Liver carcinoma

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

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

Organ function | Bone Marrow function

Tipo de datos

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
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

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

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure | major surgery

Tipo de datos

boolean

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

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
known brain metastases
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

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

Liver carcinoma Score

Tipo de datos

boolean

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

Chronic diarrhea | Disease Limiting SU 11248 Absorption

Tipo de datos

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
Descripción

Electrocardiogram QT corrected interval prolonged | Prolonged QTc Family history

Tipo de datos

boolean

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

Comorbidity Uncontrolled

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Protein g/24h

Tipo de datos

boolean

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

Eligibility Hepatocellular Carcinoma NCT00361309

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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