ID

36064

Descrição

A Phase 1 Study of BLU-554 in Patients With Hepatocellular Carcinoma and Cholangiocarcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02508467

Link

https://clinicaltrials.gov/show/NCT02508467

Palavras-chave

Versões (2)
  1. 12/04/2019 12/04/2019 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma (HCC) NCT02508467

Inglês

Eligibility Hepatocellular Carcinoma (HCC) NCT02508467

1 Formulários  
Criteria
Descrição

Criteria

for parts 1 and 2, confirmed diagnosis of hcc by histological examination or by non-invasive criteria according to (european association for the study of the liver (easl) or american association for the study of liver disease (aasld) guidelines. patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
Descrição

Liver carcinoma | Disease unresectable | Prior Therapy Sorafenib | Sorafenib Rejected | Sorafenib Unavailable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1516119
UMLS CUI [4,1]
C1516119
UMLS CUI [4,2]
C1548437
UMLS CUI [5,1]
C1516119
UMLS CUI [5,2]
C0686905
or for part 2: confirmed diagnosis of cholangiocarcinoma with unresectable disease
Descrição

Cholangiocarcinoma | Disease unresectable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206698
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1519810
child-pugh class a with no clinically apparent ascites
Descrição

Child-Pugh Classification | Ascites Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0332197
eastern cooperative oncology group (ecog) performance status of 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
willing to provide archived tumor tissue (if available) and willing to undergo pre-
Descrição

Tumor tissue sample | Tumor Biopsy Pretreatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C3539076
and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
Descrição

Tumor Biopsy During Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0087111
key exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
central nervous system metastases
Descrição

CNS metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
platelet count <75,000/ml
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
absolute neutrophil count <1000/ml
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin <8 g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
aspartate aminotransferase (ast) or alanine aminotransferase (alt) >5x the upper limit of normal (uln)
Descrição

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
total bilirubin >2.5 mg/dl
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
international normalized ratio (inr) >2.3 or prothrombin time (pt) >6 seconds above control
Descrição

International Normalized Ratio | Prothrombin time test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0491338
estimated (cockroft-gault formula) or measured creatinine clearance <40 ml/min
Descrição

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
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Similar models

Eligibility Hepatocellular Carcinoma (HCC) NCT02508467

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Liver carcinoma | Disease unresectable | Prior Therapy Sorafenib | Sorafenib Rejected | Sorafenib Unavailable
Item
for parts 1 and 2, confirmed diagnosis of hcc by histological examination or by non-invasive criteria according to (european association for the study of the liver (easl) or american association for the study of liver disease (aasld) guidelines. patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
boolean
C2239176 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C1516119 (UMLS CUI [4,1])
C1548437 (UMLS CUI [4,2])
C1516119 (UMLS CUI [5,1])
C0686905 (UMLS CUI [5,2])
Cholangiocarcinoma | Disease unresectable
Item
or for part 2: confirmed diagnosis of cholangiocarcinoma with unresectable disease
boolean
C0206698 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Child-Pugh Classification | Ascites Absent
Item
child-pugh class a with no clinically apparent ascites
boolean
C2347612 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Tumor tissue sample | Tumor Biopsy Pretreatment
Item
willing to provide archived tumor tissue (if available) and willing to undergo pre-
boolean
C0475358 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C3539076 (UMLS CUI [2,3])
Tumor Biopsy During Therapeutic procedure
Item
and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
CNS metastases
Item
central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count <75,000/ml
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count <1000/ml
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin <8 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt) >5x the upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin >2.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
International Normalized Ratio | Prothrombin time test
Item
international normalized ratio (inr) >2.3 or prothrombin time (pt) >6 seconds above control
boolean
C0525032 (UMLS CUI [1])
C0491338 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
estimated (cockroft-gault formula) or measured creatinine clearance <40 ml/min
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
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