ID

30379

Beschrijving

A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT00677105

Link

https://clinicaltrials.gov/show/NCT00677105

Trefwoorden

Versies (1)
  1. 30-05-18 30-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00677105

Engels

Eligibility Lymphoma NCT00677105

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00677105
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective
Beschrijving

Solid Neoplasm | Malignant lymphoma, metastatic | Lymphoma unresectable | Absence Standard of Care Curative | Standard Palliative Care Absent | Standard of Care Curative ineffective | Standard Palliative Care ineffective

Datatype

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2]
C1266190
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2936643
UMLS CUI [4,3]
C1276305
UMLS CUI [5,1]
C1442989
UMLS CUI [5,2]
C0030231
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C1276305
UMLS CUI [6,3]
C3242229
UMLS CUI [7,1]
C1442989
UMLS CUI [7,2]
C0030231
UMLS CUI [7,3]
C3242229
performance status (based on the eastern cooperative oncology group assessments) of <= 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
adequate gastrointestinal absorption status
Beschrijving

Gastrointestinal Absorption Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714657
UMLS CUI [1,2]
C0449438
adequate liver, kidney and bone marrow function
Beschrijving

Liver function | Renal function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
adequate heart function (left ventricular ejection fraction >= 50%)
Beschrijving

Cardiac function | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known brain metastases
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
chemotherapy (in the case of nitrosoureas and mitomycin c within 6 weeks), radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks before study drug administration
Beschrijving

Chemotherapy | Nitrosourea | Mitomycin | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0028210
UMLS CUI [3]
C0002475
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0013230
history of uncontrolled heart disease or uncontrolled arterial hypertension (protocol-defined)
Beschrijving

Heart Disease Uncontrolled | Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
patients taking medications known to have a risk of causing heart function abnormalities (i.e.
Beschrijving

Pharmaceutical Preparations At risk Cardiac function Abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0232164
UMLS CUI [1,4]
C1704258
qtc prolongation and torsades de pointes)
Beschrijving

Prolonged QTc | Torsades de Pointes

Datatype

boolean

Alias
UMLS CUI [1]
C1969409
UMLS CUI [2]
C0040479
neuropathy (malfunction of the nerves) at baseline of grade > = 2
Beschrijving

Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
positive serology for hepatitis b, hepatitis c or human immunodeficiency virus (hiv)
Beschrijving

Serology positive Hepatitis B | Serology positive Hepatitis C | HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019196
UMLS CUI [3]
C0019699
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Similar models

Eligibility Lymphoma NCT00677105

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00677105
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Solid Neoplasm | Malignant lymphoma, metastatic | Lymphoma unresectable | Absence Standard of Care Curative | Standard Palliative Care Absent | Standard of Care Curative ineffective | Standard Palliative Care ineffective
Item
confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective
boolean
C0280100 (UMLS CUI [1])
C1266190 (UMLS CUI [2])
C0024299 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C2936643 (UMLS CUI [4,2])
C1276305 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C0030231 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C2936643 (UMLS CUI [6,1])
C1276305 (UMLS CUI [6,2])
C3242229 (UMLS CUI [6,3])
C1442989 (UMLS CUI [7,1])
C0030231 (UMLS CUI [7,2])
C3242229 (UMLS CUI [7,3])
ECOG performance status
Item
performance status (based on the eastern cooperative oncology group assessments) of <= 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Gastrointestinal Absorption Status
Item
adequate gastrointestinal absorption status
boolean
C3714657 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Liver function | Renal function | Bone Marrow function
Item
adequate liver, kidney and bone marrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Cardiac function | Left ventricular ejection fraction
Item
adequate heart function (left ventricular ejection fraction >= 50%)
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Chemotherapy | Nitrosourea | Mitomycin | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs
Item
chemotherapy (in the case of nitrosoureas and mitomycin c within 6 weeks), radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks before study drug administration
boolean
C0392920 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0002475 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Heart Disease Uncontrolled | Uncontrolled hypertension
Item
history of uncontrolled heart disease or uncontrolled arterial hypertension (protocol-defined)
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
Pharmaceutical Preparations At risk Cardiac function Abnormality
Item
patients taking medications known to have a risk of causing heart function abnormalities (i.e.
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0232164 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
Prolonged QTc | Torsades de Pointes
Item
qtc prolongation and torsades de pointes)
boolean
C1969409 (UMLS CUI [1])
C0040479 (UMLS CUI [2])
Neuropathy CTCAE Grades
Item
neuropathy (malfunction of the nerves) at baseline of grade > = 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Serology positive Hepatitis B | Serology positive Hepatitis C | HIV Seropositivity
Item
positive serology for hepatitis b, hepatitis c or human immunodeficiency virus (hiv)
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
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