ID

14848

Descripción

A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01839604

Link

https://clinicaltrials.gov/show/NCT01839604

Palabras clave

Versiones (1)
  1. 1/5/16 1/5/16 -
Subido en

1 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Advanced Adult Hepatocellular Carcinoma NCT01839604

Inglés

Eligibility Advanced Adult Hepatocellular Carcinoma NCT01839604

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged at least 18 years. patient from japan and taiwan aged at least 20 years
Descripción

age and japanese, taiwanese

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1556094
UMLS CUI [3]
C1556096
histologically or cytologically confirmed hcc (with the exception of fibrolamellar carcinoma or mixed variants of hcc with fibrolamellar histology or clinically diagnosed hcc for patients with difficulty in obtaining histological diagnosis)
Descripción

hcc

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
Descripción

sorafenib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516119
hcc not suitable to receive local therapy
Descripción

hcc not suitable to receive local therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1517925
disease recurred or was refractory to last therapy (local or systemic)
Descripción

disease recurred or was refractory to last therapy (local or systemic)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0854794
eastern cooperative oncology group (ecog) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks
Descripción

ecog

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 2 prior systemic treatments for hcc
Descripción

systemic treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
prior grade 3 hematologic toxicity related to treatment with a jak or stat3 inhibitor
Descripción

prior grade 3 hematologic toxicity related to treatment with a jak or stat3 inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3827109
UMLS CUI [2]
C2983787
UMLS CUI [3]
C0279037
presence of hepatic encephalopathy within 4 weeks of 1st dose
Descripción

hepatic encephalopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019151
uncontrolled massive ascites
Descripción

ascites

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003962
high likelihood of bleeding
Descripción

bleeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4039184
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Similar models

Eligibility Advanced Adult Hepatocellular Carcinoma NCT01839604

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age and japanese, taiwanese
Item
aged at least 18 years. patient from japan and taiwan aged at least 20 years
boolean
C0001779 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
C1556096 (UMLS CUI [3])
hcc
Item
histologically or cytologically confirmed hcc (with the exception of fibrolamellar carcinoma or mixed variants of hcc with fibrolamellar histology or clinically diagnosed hcc for patients with difficulty in obtaining histological diagnosis)
boolean
C2239176 (UMLS CUI [1])
sorafenib
Item
relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
boolean
C1516119 (UMLS CUI [1])
hcc not suitable to receive local therapy
Item
hcc not suitable to receive local therapy
boolean
C2239176 (UMLS CUI [1,1])
C1517925 (UMLS CUI [1,2])
disease recurred or was refractory to last therapy (local or systemic)
Item
disease recurred or was refractory to last therapy (local or systemic)
boolean
C0854794 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group (ecog) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systemic treatment
Item
more than 2 prior systemic treatments for hcc
boolean
C0920425 (UMLS CUI [1])
prior grade 3 hematologic toxicity related to treatment with a jak or stat3 inhibitor
Item
prior grade 3 hematologic toxicity related to treatment with a jak or stat3 inhibitor
boolean
C3827109 (UMLS CUI [1])
C2983787 (UMLS CUI [2])
C0279037 (UMLS CUI [3])
hepatic encephalopathy
Item
presence of hepatic encephalopathy within 4 weeks of 1st dose
boolean
C0019151 (UMLS CUI [1])
ascites
Item
uncontrolled massive ascites
boolean
C0003962 (UMLS CUI [1])
bleeding
Item
high likelihood of bleeding
boolean
C4039184 (UMLS CUI [1])
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