ID

31053

Beskrivning

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00707304

Länk

https://clinicaltrials.gov/show/NCT00707304

Nyckelord

Versioner (1)
  1. 2018-07-14 2018-07-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00707304

Engelsk

Eligibility Non Small Cell Lung Cancer NCT00707304

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed stage iiib or iv nsclc
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic nsclc
Beskrivning

Cancer treatment Systemic Quantity failed | Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C0278987
at least one target lesion that is unirradiated and measurable by recist
Beskrivning

Target Lesion Quantity Without Irradiation | Target Lesion Measurable Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C1522449
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C1265611
adequate hematologic, renal and hepatic function
Beskrivning

Hematologic function | Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
ecog 0, 1, or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
able to understand and sign an informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
Beskrivning

Metastatic malignant neoplasm to brain | Exception Irradiation of whole brain | Exception Stereotactic Radiosurgery | Exception Patient's condition stable | Exception Patient Asymptomatic | Exception Steroids Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2064932
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3846112
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1282982
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0030705
UMLS CUI [5,3]
C0231221
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0038317
UMLS CUI [6,3]
C1444662
any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
Beskrivning

Gastrointestinal Disease | Other medical condition | Lacking Able to swallow Oral medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C3843040
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0175795
history of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
Beskrivning

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Prostate carcinoma | Exception Curative treatment Superficial carcinoma of urinary bladder | Exception Curative treatment Solid Neoplasm | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0600139
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C1336527
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1273390
UMLS CUI [7,3]
C0280100
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0012634
UMLS CUI [8,3]
C0332296
uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
Beskrivning

Myocardial Ischemia Uncontrolled | Symptomatic congestive heart failure Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0742758
UMLS CUI [2,2]
C0205318
serious active infection
Beskrivning

Communicable Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
psychiatric illness/ social situations that would limit study compliance
Beskrivning

Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Beskrivning

Chronic disease Serious Uncontrolled | Condition Affecting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
Beskrivning

Therapeutic radiology procedure Site Any | Therapeutic radiology procedure Recent | Prior radiation therapy Target Lesion Site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C2986546
UMLS CUI [3,3]
C1515974
known hiv positive or on active anti-retroviral therapy
Beskrivning

HIV Seropositivity | Antiretroviral therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1963724
known hepatitis b surface antigen positive or hepatitis c positive
Beskrivning

Hepatitis B surface antigen positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C1112419
receipt of any investigational medication within 4 weeks prior to randomization
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0240802
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
Beskrivning

Gender Sexually active | Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Beskrivning

Legal capacity Lacking | Legal capacity Limited | Exception Authorization Legal Guardians

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0680281
UMLS CUI [3,3]
C0023226
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00707304

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically or cytologically confirmed stage iiib or iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Cancer treatment Systemic Quantity failed | Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic
Item
failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic nsclc
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0278987 (UMLS CUI [3])
Target Lesion Quantity Without Irradiation | Target Lesion Measurable Quantity
Item
at least one target lesion that is unirradiated and measurable by recist
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
ECOG performance status
Item
ecog 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
able to understand and sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Exception Irradiation of whole brain | Exception Stereotactic Radiosurgery | Exception Patient's condition stable | Exception Patient Asymptomatic | Exception Steroids Discontinued
Item
presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2064932 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3846112 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1282982 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C0231221 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0038317 (UMLS CUI [6,2])
C1444662 (UMLS CUI [6,3])
Gastrointestinal Disease | Other medical condition | Lacking Able to swallow Oral medication
Item
any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
boolean
C0017178 (UMLS CUI [1])
C3843040 (UMLS CUI [2])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0175795 (UMLS CUI [3,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Prostate carcinoma | Exception Curative treatment Superficial carcinoma of urinary bladder | Exception Curative treatment Solid Neoplasm | Exception Disease Free of
Item
history of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0600139 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C1336527 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0280100 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
C0332296 (UMLS CUI [8,3])
Myocardial Ischemia Uncontrolled | Symptomatic congestive heart failure Uncontrolled
Item
uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
boolean
C0151744 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Communicable Disease Serious
Item
serious active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
psychiatric illness/ social situations that would limit study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Chronic disease Serious Uncontrolled | Condition Affecting Protocol Compliance
Item
other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
boolean
C0008679 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Therapeutic radiology procedure Site Any | Therapeutic radiology procedure Recent | Prior radiation therapy Target Lesion Site
Item
concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
boolean
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C2986546 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
HIV Seropositivity | Antiretroviral therapy
Item
known hiv positive or on active anti-retroviral therapy
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis C positive
Item
known hepatitis b surface antigen positive or hepatitis c positive
boolean
C0149709 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Investigational New Drugs
Item
receipt of any investigational medication within 4 weeks prior to randomization
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling
Item
pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0240802 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Gender Sexually active | Contraceptive methods Unwilling
Item
sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Legal capacity Lacking | Legal capacity Limited | Exception Authorization Legal Guardians
Item
legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0680281 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
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