ID

33568

Description

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01719380

Link

https://clinicaltrials.gov/show/NCT01719380

Keywords

  1. 12/13/18 12/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 13, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT01719380

Eligibility Colorectal Cancer NCT01719380

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic colorectal cancer
Description

Secondary malignant neoplasm of large intestine

Data type

boolean

Alias
UMLS CUI [1]
C0346973
progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
Description

Disease Progression | Status post Standard of Care Quantity | Intolerance to Irinotecan

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0123931
life expectancy ≥ 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic or untreated leptomeningeal disease
Description

Leptomeningeal disease Symptomatic | Leptomeningeal disease Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0751297
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0751297
UMLS CUI [2,2]
C0332155
symptomatic brain metastasis
Description

Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
patients with clinically manifested diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
acute or chronic pancreatitis
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
clinically significant cardiac disease
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Colorectal Cancer NCT01719380

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of large intestine
Item
metastatic colorectal cancer
boolean
C0346973 (UMLS CUI [1])
Disease Progression | Status post Standard of Care Quantity | Intolerance to Irinotecan
Item
progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0123931 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Leptomeningeal disease Symptomatic | Leptomeningeal disease Untreated
Item
symptomatic or untreated leptomeningeal disease
boolean
C0751297 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Diabetes Mellitus
Item
patients with clinically manifested diabetes
boolean
C0011849 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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