ID

17290

Descrição

Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01737827

Link

https://clinicaltrials.gov/show/NCT01737827

Palavras-chave

  1. 04/09/2016 04/09/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

4 de setembro de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed c-met pathway dysregulation
Descrição

confirmed c-met pathway dysregulation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1456828
UMLS CUI [1,2]
C1836729
advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
Descrição

hepatocellular carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
measurable disease as determined by recist version
Descrição

measurable disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
current cirrhotic status of child-pugh class a with no encephalopathy
Descrição

child-pugh class a

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347612
eastern cooperative oncology group (ecog) performance status < or = 2.
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
other protocol-defined inclusion criteria may apply.
Descrição

inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
Descrição

systemic chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1883256
previous treatment with c-met inhibitor or hepatocyte growth factor targeting therapy.
Descrição

c-met inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2697591
previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
Descrição

local therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1517925
known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
Descrição

active bleeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
clinically significant venous or arterial thrombotic disease within past 6 months.
Descrição

venous or arterial thrombotic disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4049573
history of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
Descrição

acute or chronic pancreatitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0262417
other protocol-defined exclusion criteria may apply.
Descrição

exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251

Similar models

Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
confirmed c-met pathway dysregulation
Item
confirmed c-met pathway dysregulation
boolean
C1456828 (UMLS CUI [1,1])
C1836729 (UMLS CUI [1,2])
hepatocellular carcinoma
Item
advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
boolean
C2239176 (UMLS CUI [1])
measurable disease
Item
measurable disease as determined by recist version
boolean
C1513041 (UMLS CUI [1])
child-pugh class a
Item
current cirrhotic status of child-pugh class a with no encephalopathy
boolean
C2347612 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group (ecog) performance status < or = 2.
boolean
C1520224 (UMLS CUI [1])
inclusion criteria
Item
other protocol-defined inclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systemic chemotherapy
Item
received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
boolean
C1883256 (UMLS CUI [1])
c-met inhibitor
Item
previous treatment with c-met inhibitor or hepatocyte growth factor targeting therapy.
boolean
C2697591 (UMLS CUI [1])
local therapy
Item
previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
boolean
C1517925 (UMLS CUI [1])
active bleeding
Item
known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
boolean
C0019080 (UMLS CUI [1])
venous or arterial thrombotic disease
Item
clinically significant venous or arterial thrombotic disease within past 6 months.
boolean
C4049573 (UMLS CUI [1])
acute or chronic pancreatitis
Item
history of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
boolean
C0262417 (UMLS CUI [1])
exclusion criteria
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1])

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