ID

44549

Beschrijving

Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02191878

Link

https://clinicaltrials.gov/show/NCT02191878

Trefwoorden

Versies (2)
  1. 23-02-20 23-02-20 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02191878

Engels

Eligibility Hepatocellular Carcinoma NCT02191878

1 Formulieren  
Criteria
Beschrijving

Criteria

child-pugh class of a
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C4050412
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤5.0 × uln
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin ≤3.0 mg/dl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
platelets ≥75,000 /ml
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
international normalized ratio (inr) ≤1.7
Beschrijving

International Normalized Ratio

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
subjects must meet the protocol-defined criteria for both hepatitis b virus (hbv) and hepatitis c virus (hcv) status
Beschrijving

Study Protocol Criteria Fulfill | Hepatitis B Status | Hepatitis C Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0449438
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0449438
key exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
history of significant cardiovascular disease will be excluded
Beschrijving

Cardiovascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
history of liver transplant.
Beschrijving

Transplantation of liver

Datatype

boolean

Alias
UMLS CUI [1]
C0023911
diagnosis of fibrolamellar hcc or tumors of mixed histology.
Beschrijving

Fibrolamellar Hepatocellular Carcinoma | Neoplasms Histology Mixed

Datatype

boolean

Alias
UMLS CUI [1]
C0334287
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C4048239
UMLS CUI [2,3]
C0205430
subjects known to be positive for human immunodeficiency virus (hiv) infection.
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
known central nervous system (cns) or brain metastases.
Beschrijving

CNS metastases | Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
Beschrijving

Ascites Poorly controlled | Requirement Paracentesis Frequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0034115
UMLS CUI [2,3]
C0439603
symptomatic encephalopathy within 3 months prior to the first dose of tkm-080301 and/or requirement for medication for encephalopathy.
Beschrijving

Encephalopathy Symptomatic | Requirement Pharmaceutical Preparations Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085584
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0085584
esophageal variceal bleeding within 2 weeks prior to the first dose of tkm-080301.
Beschrijving

Bleeding esophageal varices

Datatype

boolean

Alias
UMLS CUI [1]
C0155789
asthma or chronic obstructive pulmonary disease (copd) requiring daily medication.
Beschrijving

Asthma | Chronic Obstructive Airway Disease | Requirement Pharmaceutical Preparations Daily

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0024117
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0332173
prior therapy with nitrosoureas or mitomycin within 6 weeks prior to the first dose of tkm-080301.
Beschrijving

Prior Therapy | Nitrosoureas | Mitomycin

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0028210
UMLS CUI [3]
C0002475
prior therapy with any biologic chemotherapeutic or investigational drug within 5 half-lives or 3 weeks, whichever is longer prior to the first dose of tkm 080301.
Beschrijving

Prior Therapy | Biological agents | Antineoplastic Agents | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0005515
UMLS CUI [3]
C0003392
UMLS CUI [4]
C0013230
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Similar models

Eligibility Hepatocellular Carcinoma NCT02191878

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Child-Pugh Classification
Item
child-pugh class of a
boolean
C4050412 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤5.0 × uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin ≤3.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥75,000 /ml
boolean
C0032181 (UMLS CUI [1])
International Normalized Ratio
Item
international normalized ratio (inr) ≤1.7
boolean
C0525032 (UMLS CUI [1])
Study Protocol Criteria Fulfill | Hepatitis B Status | Hepatitis C Status
Item
subjects must meet the protocol-defined criteria for both hepatitis b virus (hbv) and hepatitis c virus (hcv) status
boolean
C2348563 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0019163 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cardiovascular Disease
Item
history of significant cardiovascular disease will be excluded
boolean
C0007222 (UMLS CUI [1])
Transplantation of liver
Item
history of liver transplant.
boolean
C0023911 (UMLS CUI [1])
Fibrolamellar Hepatocellular Carcinoma | Neoplasms Histology Mixed
Item
diagnosis of fibrolamellar hcc or tumors of mixed histology.
boolean
C0334287 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
HIV Seropositivity
Item
subjects known to be positive for human immunodeficiency virus (hiv) infection.
boolean
C0019699 (UMLS CUI [1])
CNS metastases | Metastatic malignant neoplasm to brain
Item
known central nervous system (cns) or brain metastases.
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Ascites Poorly controlled | Requirement Paracentesis Frequency
Item
poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
boolean
C0003962 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0034115 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
Encephalopathy Symptomatic | Requirement Pharmaceutical Preparations Encephalopathy
Item
symptomatic encephalopathy within 3 months prior to the first dose of tkm-080301 and/or requirement for medication for encephalopathy.
boolean
C0085584 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0085584 (UMLS CUI [2,3])
Bleeding esophageal varices
Item
esophageal variceal bleeding within 2 weeks prior to the first dose of tkm-080301.
boolean
C0155789 (UMLS CUI [1])
Asthma | Chronic Obstructive Airway Disease | Requirement Pharmaceutical Preparations Daily
Item
asthma or chronic obstructive pulmonary disease (copd) requiring daily medication.
boolean
C0004096 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Prior Therapy | Nitrosoureas | Mitomycin
Item
prior therapy with nitrosoureas or mitomycin within 6 weeks prior to the first dose of tkm-080301.
boolean
C1514463 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0002475 (UMLS CUI [3])
Prior Therapy | Biological agents | Antineoplastic Agents | Investigational New Drugs
Item
prior therapy with any biologic chemotherapeutic or investigational drug within 5 half-lives or 3 weeks, whichever is longer prior to the first dose of tkm 080301.
boolean
C1514463 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C0003392 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
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