ID

38608

Beschrijving

c-Met Second-Line Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02115373

Link

https://clinicaltrials.gov/show/NCT02115373

Trefwoorden

Versies (2)
  1. 28-10-19 28-10-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 oktober 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT02115373

Engels

Eligibility Carcinoma, Hepatocellular NCT02115373

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed hcc
Beschrijving

Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
child pugh class a liver function score
Beschrijving

Liver function Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
for phase 2 only: met+ status
Beschrijving

MET Positive

Datatype

boolean

Alias
UMLS CUI [1]
C4330600
male or female, 18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
measurable disease in accordance with response evaluation criteria in solid tumors (recist) version 1.1
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status (ps) 0-1 (inclusive)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with msc2156119j. from the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. an associated pathology report must also be sent with the sample
Beschrijving

Tumor Biopsy Pretreatment | Exception Fine needle aspiration biopsy | Exception Cytologic material | Sorafenib Discontinued | Tepotinib | Tumor tissue Formalin-fixed paraffin-embedded tissue specimen Block | Unstained Specimen Quantity | Pathology report

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C3539076
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1510483
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0225355
UMLS CUI [4,1]
C1516119
UMLS CUI [4,2]
C1444662
UMLS CUI [5]
C4287799
UMLS CUI [6,1]
C0475358
UMLS CUI [6,2]
C2711483
UMLS CUI [6,3]
C1533157
UMLS CUI [7,1]
C1883469
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0807321
previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to day 1 due to either intolerance or radiographic progression
Beschrijving

Sorafenib | Sorafenib Discontinued | Intolerance to Sorafenib | Disease Progression Radiography

Datatype

boolean

Alias
UMLS CUI [1]
C1516119
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1516119
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0034571
signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
life expectancy of at least 3 months as judged by the investigator
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic anticancer treatment for advanced hcc (except for sorafenib as described in the inclusion criteria)
Beschrijving

Cancer treatment Systemic Advanced Adult Hepatocellular Carcinoma | Exception Sorafenib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1706732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1516119
prior treatment with any agent targeting the hepatocyte growth factor (hgf)/c-met pathway
Beschrijving

Targeted Therapy Hepatocyte Growth Factor | Targeted Therapy C-MET

Datatype

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0062534
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1456828
local-regional therapy within 4 weeks before day 1
Beschrijving

Therapy Local-Regional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1947913
impaired cardiac function
Beschrijving

Decreased cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C0232166
other protocol defined exclusion criteria could apply
Beschrijving

Exclusion Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Carcinoma, Hepatocellular NCT02115373

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
histologically or cytologically confirmed hcc
boolean
C2239176 (UMLS CUI [1])
Liver function Child-Pugh Classification
Item
child pugh class a liver function score
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
MET Positive
Item
for phase 2 only: met+ status
boolean
C4330600 (UMLS CUI [1])
Age
Item
male or female, 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
measurable disease in accordance with response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) 0-1 (inclusive)
boolean
C1520224 (UMLS CUI [1])
Tumor Biopsy Pretreatment | Exception Fine needle aspiration biopsy | Exception Cytologic material | Sorafenib Discontinued | Tepotinib | Tumor tissue Formalin-fixed paraffin-embedded tissue specimen Block | Unstained Specimen Quantity | Pathology report
Item
availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with msc2156119j. from the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. an associated pathology report must also be sent with the sample
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0225355 (UMLS CUI [3,2])
C1516119 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C4287799 (UMLS CUI [5])
C0475358 (UMLS CUI [6,1])
C2711483 (UMLS CUI [6,2])
C1533157 (UMLS CUI [6,3])
C1883469 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0807321 (UMLS CUI [8])
Sorafenib | Sorafenib Discontinued | Intolerance to Sorafenib | Disease Progression Radiography
Item
previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to day 1 due to either intolerance or radiographic progression
boolean
C1516119 (UMLS CUI [1])
C1516119 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
Informed Consent | Informed Consent Patient Representative
Item
signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
boolean
C0525058 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months as judged by the investigator
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic Advanced Adult Hepatocellular Carcinoma | Exception Sorafenib
Item
prior systemic anticancer treatment for advanced hcc (except for sorafenib as described in the inclusion criteria)
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1706732 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
Targeted Therapy Hepatocyte Growth Factor | Targeted Therapy C-MET
Item
prior treatment with any agent targeting the hepatocyte growth factor (hgf)/c-met pathway
boolean
C2985566 (UMLS CUI [1,1])
C0062534 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C1456828 (UMLS CUI [2,2])
Therapy Local-Regional
Item
local-regional therapy within 4 weeks before day 1
boolean
C0087111 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
Decreased cardiac function
Item
impaired cardiac function
boolean
C0232166 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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