Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed c-met pathway dysregulation
Beschrijving

confirmed c-met pathway dysregulation

Datatype

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.
Beschrijving

hepatocellular carcinoma

Datatype

boolean

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

measurable disease

Datatype

boolean

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

child-pugh class a

Datatype

boolean

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

ecog

Datatype

boolean

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

inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

systemic chemotherapy

Datatype

boolean

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

c-met inhibitor

Datatype

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.
Beschrijving

local therapy

Datatype

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.
Beschrijving

active bleeding

Datatype

boolean

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

venous or arterial thrombotic disease

Datatype

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.
Beschrijving

acute or chronic pancreatitis

Datatype

boolean

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

exclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251

Similar models

Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])