ID

17290

Beschreibung

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

Stichworte

  1. 04.09.16 04.09.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

4. September 2016

DOI

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Lizenz

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
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed c-met pathway dysregulation
Beschreibung

confirmed c-met pathway dysregulation

Datentyp

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.
Beschreibung

hepatocellular carcinoma

Datentyp

boolean

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

measurable disease

Datentyp

boolean

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

child-pugh class a

Datentyp

boolean

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

ecog

Datentyp

boolean

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

inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

systemic chemotherapy

Datentyp

boolean

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

c-met inhibitor

Datentyp

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.
Beschreibung

local therapy

Datentyp

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.
Beschreibung

active bleeding

Datentyp

boolean

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

venous or arterial thrombotic disease

Datentyp

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.
Beschreibung

acute or chronic pancreatitis

Datentyp

boolean

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

exclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251

Ähnliche Modelle

Eligibility Advanced Hepatocellular Carcinoma With c-MET Dysregulation NCT01737827

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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