ID

44507

Descripción

A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02178358

Link

https://clinicaltrials.gov/show/NCT02178358

Palabras clave

Versiones (2)
  1. 18/5/20 18/5/20 -
  2. 27/9/21 27/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02178358

Inglés

Eligibility Hepatocellular Carcinoma NCT02178358

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
have histological evidence of a diagnosis of hcc not amenable to curative surgery.
Descripción

Liver carcinoma Inappropriate Curative Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1511562
have child-pugh class a.
Descripción

Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4050412
have the presence of measurable disease.
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
have adequate organ function.
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
have a performance status of ≤1 on the eastern cooperative oncology group (ecog) scale.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
if male or female with reproductive potential, must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
Descripción

Females & males of reproductive potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
if females with childbearing potential, must have had a negative serum pregnancy test 7 days prior to the first dose of study drug.
Descripción

Childbearing Potential Serum pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
are able to swallow capsules or tablets.
Descripción

Able to swallow Capsules | Able to swallow Tablets

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
UMLS CUI [2,1]
C2712086
UMLS CUI [2,2]
C0039225
have available diagnostic or biopsy tumor tissue.
Descripción

Availability of Tumor tissue Diagnostic | Availability of Biopsy Tumor tissue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0011900
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0475358
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received previous systemic treatment for advanced disease.
Descripción

Systemic therapy Advanced disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0679246
have known hcc with fibro-lamellar or mixed histology.
Descripción

Fibrolamellar Hepatocellular Carcinoma | Liver carcinoma Histology Mixed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0334287
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C4048239
UMLS CUI [2,3]
C0205430
have presence of clinically relevant ascites.
Descripción

Ascites

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003962
have had a liver transplant.
Descripción

Transplantation of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023911
have moderate or severe cardiac disease.
Descripción

Heart Disease Moderate | Heart Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
have active or uncontrolled clinically serious hepatitis b virus or hepatitis c virus infection.
Descripción

Hepatitis B Serious | Hepatitis C Serious | Hepatitis B Serious Uncontrolled | Hepatitis C Serious Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0019163
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0205318
have experienced grade 3 or 4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention.
Descripción

Gastrointestinal Hemorrhage Grade | Episode of Variceal hemorrhage | Requirement Transfusion | Requirement Intervention Endoscopic | Requirement Surgical intervention

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0333106
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0005841
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0184661
UMLS CUI [4,3]
C0442418
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0549433
have esophageal or gastric varices that require immediate intervention or represent a high bleeding risk.
Descripción

Esophageal Varices | Gastric Varices | Requirement Intervention Immediate | High risk of bleeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014867
UMLS CUI [2]
C0017145
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0205253
UMLS CUI [4]
C4039184
had major surgery within 4 weeks prior to the study randomization.
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Hepatocellular Carcinoma NCT02178358

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma Inappropriate Curative Surgery
Item
have histological evidence of a diagnosis of hcc not amenable to curative surgery.
boolean
C2239176 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
Child-Pugh Classification
Item
have child-pugh class a.
boolean
C4050412 (UMLS CUI [1])
Measurable Disease
Item
have the presence of measurable disease.
boolean
C1513041 (UMLS CUI [1])
Organ function
Item
have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
ECOG performance status
Item
have a performance status of ≤1 on the eastern cooperative oncology group (ecog) scale.
boolean
C1520224 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
if male or female with reproductive potential, must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Childbearing Potential Serum pregnancy test negative
Item
if females with childbearing potential, must have had a negative serum pregnancy test 7 days prior to the first dose of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Able to swallow Capsules | Able to swallow Tablets
Item
are able to swallow capsules or tablets.
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C2712086 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
Availability of Tumor tissue Diagnostic | Availability of Biopsy Tumor tissue
Item
have available diagnostic or biopsy tumor tissue.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0475358 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Advanced disease
Item
have received previous systemic treatment for advanced disease.
boolean
C1515119 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
Fibrolamellar Hepatocellular Carcinoma | Liver carcinoma Histology Mixed
Item
have known hcc with fibro-lamellar or mixed histology.
boolean
C0334287 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
Ascites
Item
have presence of clinically relevant ascites.
boolean
C0003962 (UMLS CUI [1])
Transplantation of liver
Item
have had a liver transplant.
boolean
C0023911 (UMLS CUI [1])
Heart Disease Moderate | Heart Disease Severe
Item
have moderate or severe cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Hepatitis B Serious | Hepatitis C Serious | Hepatitis B Serious Uncontrolled | Hepatitis C Serious Uncontrolled
Item
have active or uncontrolled clinically serious hepatitis b virus or hepatitis c virus infection.
boolean
C0019163 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0019163 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0019196 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
Gastrointestinal Hemorrhage Grade | Episode of Variceal hemorrhage | Requirement Transfusion | Requirement Intervention Endoscopic | Requirement Surgical intervention
Item
have experienced grade 3 or 4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention.
boolean
C0017181 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0333106 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0005841 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C0442418 (UMLS CUI [4,3])
C1514873 (UMLS CUI [5,1])
C0549433 (UMLS CUI [5,2])
Esophageal Varices | Gastric Varices | Requirement Intervention Immediate | High risk of bleeding
Item
have esophageal or gastric varices that require immediate intervention or represent a high bleeding risk.
boolean
C0014867 (UMLS CUI [1])
C0017145 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0205253 (UMLS CUI [3,3])
C4039184 (UMLS CUI [4])
Major surgery
Item
had major surgery within 4 weeks prior to the study randomization.
boolean
C0679637 (UMLS CUI [1])
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