ID

22435

Beskrivning

Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Patients With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00533429

Länk

https://clinicaltrials.gov/show/NCT00533429

Nyckelord

Versioner (1)
  1. 2017-06-04 2017-06-04 -
Uppladdad den

4 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00533429

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00533429

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
they or their legal representative must have signed an informed consent document for clinical research
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
have laboratory confirmed diagnosis of advanced, nonsquamous cell nsclc (stage iiib or iv disease) which is not curable
Beskrivning

nonsquamous cell nsclc, tumor stage, incurable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2585890
UMLS CUI [1,2]
C1300072
UMLS CUI [1,3]
C0175969
have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced nsclc, prior radiation therapy is allowed to less than 25% of the bone marrow
Beskrivning

prior therapy, chemotherapy, immunotherapy, targeted therapy, or biological therapy, prior radiation therapy, advanced nsclc

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0021083
UMLS CUI [1,4]
C2985566
UMLS CUI [1,5]
C0005527
UMLS CUI [1,6]
C0205179
UMLS CUI [1,7]
C0007131
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C0007131
have measurable disease
Beskrivning

measurable disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
have adequate organ function and estimated life expectancy of 12 weeks
Beskrivning

organ function, life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have known cns disease; major surgery within 28 days; minor surgery within 7 days; serious concommitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
Beskrivning

cns disease, major surgery; minor surgery; serious systemic disorder; serious cardiac condition; nonhealing wound, ulcer, or bone fracture

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0679637
UMLS CUI [3]
C0038904
UMLS CUI [4]
C0442893
UMLS CUI [5]
C0018799
UMLS CUI [6,1]
C0043250
UMLS CUI [6,2]
C3845448
UMLS CUI [7,1]
C0041582
UMLS CUI [7,2]
C3845448
UMLS CUI [8,1]
C0016658
UMLS CUI [8,2]
C3845448
have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
Beskrivning

prior therapy, drugs, regulatory approval

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3899556
have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
Beskrivning

prior therapy enzastaurin, pemetrexed, or bevacizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1327830
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0210657
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0796392
are pregnant or breast-feeding
Beskrivning

pregnancy, breast feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
are unable to swallow tablets
Beskrivning

are unable to swallow tablets

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0566355
UMLS CUI [1,2]
C0039225
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00533429

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
they or their legal representative must have signed an informed consent document for clinical research
boolean
C0021430 (UMLS CUI [1])
nonsquamous cell nsclc, tumor stage, incurable
Item
have laboratory confirmed diagnosis of advanced, nonsquamous cell nsclc (stage iiib or iv disease) which is not curable
boolean
C2585890 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0175969 (UMLS CUI [1,3])
prior therapy, chemotherapy, immunotherapy, targeted therapy, or biological therapy, prior radiation therapy, advanced nsclc
Item
have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced nsclc, prior radiation therapy is allowed to less than 25% of the bone marrow
boolean
C1514463 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0021083 (UMLS CUI [1,3])
C2985566 (UMLS CUI [1,4])
C0005527 (UMLS CUI [1,5])
C0205179 (UMLS CUI [1,6])
C0007131 (UMLS CUI [1,7])
C0279134 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
measurable disease
Item
have measurable disease
boolean
C1513041 (UMLS CUI [1])
organ function, life expectancy
Item
have adequate organ function and estimated life expectancy of 12 weeks
boolean
C0678852 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cns disease, major surgery; minor surgery; serious systemic disorder; serious cardiac condition; nonhealing wound, ulcer, or bone fracture
Item
have known cns disease; major surgery within 28 days; minor surgery within 7 days; serious concommitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
boolean
C0007682 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0038904 (UMLS CUI [3])
C0442893 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
C0043250 (UMLS CUI [6,1])
C3845448 (UMLS CUI [6,2])
C0041582 (UMLS CUI [7,1])
C3845448 (UMLS CUI [7,2])
C0016658 (UMLS CUI [8,1])
C3845448 (UMLS CUI [8,2])
prior therapy, drugs, regulatory approval
Item
have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
boolean
C1514463 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3899556 (UMLS CUI [1,3])
prior therapy enzastaurin, pemetrexed, or bevacizumab
Item
have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
boolean
C1514463 (UMLS CUI [1,1])
C1327830 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0210657 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0796392 (UMLS CUI [3,2])
pregnancy, breast feeding
Item
are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
are unable to swallow tablets
Item
are unable to swallow tablets
boolean
C0566355 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
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