ID

43993

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01737827

Keywords

  1. 04/09/16 04/09/16 -
  2. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

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
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed c-met pathway dysregulation
Descrizione

confirmed c-met pathway dysregulation

Tipo di dati

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.
Descrizione

hepatocellular carcinoma

Tipo di dati

boolean

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

measurable disease

Tipo di dati

boolean

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

child-pugh class a

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4050412
eastern cooperative oncology group (ecog) performance status < or = 2.
Descrizione

ecog

Tipo di dati

boolean

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

inclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Descrizione

Exclusion Criteria

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

systemic chemotherapy

Tipo di dati

boolean

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

c-met inhibitor

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4043547
previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
Descrizione

local therapy

Tipo di dati

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.
Descrizione

active bleeding

Tipo di dati

boolean

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

venous or arterial thrombotic disease

Tipo di dati

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.
Descrizione

acute or chronic pancreatitis

Tipo di dati

boolean

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

exclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251

Similar models

Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
C4050412 (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
C4043547 (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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