ID

35127

Beskrivning

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Participants With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02421185

Länk

https://clinicaltrials.gov/show/NCT02421185

Nyckelord

Versioner (1)
  1. 2019-02-18 2019-02-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT02421185

Engelsk

Eligibility Carcinoma, Hepatocellular NCT02421185

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed hepatocellular carcinoma (hcc). for part 2, hcc participants must have fibroblast growth factor (fgf) 19 amplification in addition
Beskrivning

Liver carcinoma | FGF19 gene Amplification

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1414603
UMLS CUI [2,2]
C0017256
participant must have advanced disease: disease ineligible for surgical or local-regional therapy or systemic therapy; disease progression after surgical or local-regional therapy; received no more than 1 line of systemic therapy
Beskrivning

Advanced disease | Disease Ineligible Operative Surgical Procedures | Disease Ineligible Therapy Local-Regional | Disease Ineligible Systemic therapy | Disease Progression Post Operative Surgical Procedures | Disease Progression Post Therapy Local-Regional | Systemic therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0679246
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1512714
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1512714
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C1947913
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1512714
UMLS CUI [4,3]
C1515119
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0543467
UMLS CUI [6,1]
C0242656
UMLS CUI [6,2]
C0687676
UMLS CUI [6,3]
C0087111
UMLS CUI [6,4]
C1947913
UMLS CUI [7,1]
C1515119
UMLS CUI [7,2]
C1265611
eastern cooperative oncology group (ecog) performance status score 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver, renal function, and electrolytes according to protocol-defined criteria within the 14 days preceding the first dose of study drug
Beskrivning

Bone Marrow function | Liver function | Renal function | Electrolytes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0013832
negative pregnancy test (urinary or serum beta human chorionic gonadotropin [beta (b)-hcg]) at screening for women of child bearing potential
Beskrivning

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430060
UMLS CUI [2,3]
C1513916
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
received systemic chemotherapy, targeted therapies, definitive radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug, whichever is longer (in the case of nitrosoureas and mitomycin c, within 6 weeks) before the first administration of study drug
Beskrivning

Systemic Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Immunotherapy | Antineoplastic Agents Investigational | Nitrosoureas | Mitomycin

Datatyp

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C2985566
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
UMLS CUI [5,1]
C0003392
UMLS CUI [5,2]
C1517586
UMLS CUI [6]
C0028210
UMLS CUI [7]
C0002475
prior liver transplant
Beskrivning

Transplantation of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0023911
known fibrolamellar hcc or mixed cholangiocarcinoma and hcc
Beskrivning

Fibrolamellar Hepatocellular Carcinoma | Combined Hepatocellular Carcinoma and Cholangiocarcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334287
UMLS CUI [2]
C0221287
clinically active serious infections greater than (>) common terminology criteria for adverse events (aes) grade 2
Beskrivning

Communicable Diseases Serious CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
participants with persistent calcium or phosphate > upper limits of normal (uln) during screening (within 14 days prior to day 1 of cycle 1 up until pre-dose of cycle 1) and despite medical management of calcium or phosphate levels
Beskrivning

Ca++ increased Persistent | Phosphate increased Persistent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0553702
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0860988
UMLS CUI [2,2]
C0205322
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Similar models

Eligibility Carcinoma, Hepatocellular NCT02421185

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | FGF19 gene Amplification
Item
histologically or cytologically confirmed hepatocellular carcinoma (hcc). for part 2, hcc participants must have fibroblast growth factor (fgf) 19 amplification in addition
boolean
C2239176 (UMLS CUI [1])
C1414603 (UMLS CUI [2,1])
C0017256 (UMLS CUI [2,2])
Advanced disease | Disease Ineligible Operative Surgical Procedures | Disease Ineligible Therapy Local-Regional | Disease Ineligible Systemic therapy | Disease Progression Post Operative Surgical Procedures | Disease Progression Post Therapy Local-Regional | Systemic therapy Quantity
Item
participant must have advanced disease: disease ineligible for surgical or local-regional therapy or systemic therapy; disease progression after surgical or local-regional therapy; received no more than 1 line of systemic therapy
boolean
C0679246 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1512714 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1947913 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])
C1515119 (UMLS CUI [4,3])
C0242656 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
C0242656 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C1947913 (UMLS CUI [6,4])
C1515119 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Electrolytes
Item
adequate bone marrow, liver, renal function, and electrolytes according to protocol-defined criteria within the 14 days preceding the first dose of study drug
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0013832 (UMLS CUI [4])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
negative pregnancy test (urinary or serum beta human chorionic gonadotropin [beta (b)-hcg]) at screening for women of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430060 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Systemic Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Immunotherapy | Antineoplastic Agents Investigational | Nitrosoureas | Mitomycin
Item
received systemic chemotherapy, targeted therapies, definitive radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug, whichever is longer (in the case of nitrosoureas and mitomycin c, within 6 weeks) before the first administration of study drug
boolean
C1883256 (UMLS CUI [1])
C2985566 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0003392 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0028210 (UMLS CUI [6])
C0002475 (UMLS CUI [7])
Transplantation of liver
Item
prior liver transplant
boolean
C0023911 (UMLS CUI [1])
Fibrolamellar Hepatocellular Carcinoma | Combined Hepatocellular Carcinoma and Cholangiocarcinoma
Item
known fibrolamellar hcc or mixed cholangiocarcinoma and hcc
boolean
C0334287 (UMLS CUI [1])
C0221287 (UMLS CUI [2])
Communicable Diseases Serious CTCAE Grades
Item
clinically active serious infections greater than (>) common terminology criteria for adverse events (aes) grade 2
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Ca++ increased Persistent | Phosphate increased Persistent
Item
participants with persistent calcium or phosphate > upper limits of normal (uln) during screening (within 14 days prior to day 1 of cycle 1 up until pre-dose of cycle 1) and despite medical management of calcium or phosphate levels
boolean
C0553702 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0860988 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
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