ID

33930

Description

A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02328261

Link

https://clinicaltrials.gov/show/NCT02328261

Keywords

  1. 1/8/19 1/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 8, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Nasopharyngeal Carcinoma NCT02328261

Eligibility Nasopharyngeal Carcinoma NCT02328261

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed advanced npc
Description

Nasopharyngeal carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0205179
patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
Description

Platinum Resistant | Recurrent disease | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0032207
UMLS CUI [1,2]
C0332325
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0242656
measurable disease per recist
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
adequate organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
capable of understanding and complying with the protocol, and written informed consent
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with gefitinib, erlotinib, or other drugs that target egfr
Description

gefitinib | erlotinib | Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor

Data type

boolean

Alias
UMLS CUI [1]
C1122962
UMLS CUI [2]
C1135135
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0034802
patients must not be receiving any other investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
Description

Illness Serious Treatment required for | Medical condition Treatment required for | Heart Diseases Unstable | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0497327
UMLS CUI [8]
C0036572
UMLS CUI [9,1]
C0009450
UMLS CUI [9,2]
C0205318
women who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Nasopharyngeal Carcinoma NCT02328261

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma Advanced
Item
histologically confirmed advanced npc
boolean
C2931822 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Platinum Resistant | Recurrent disease | Disease Progression
Item
patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
boolean
C0032207 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Measurable Disease
Item
measurable disease per recist
boolean
C1513041 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
capable of understanding and complying with the protocol, and written informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
gefitinib | erlotinib | Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor
Item
prior treatment with gefitinib, erlotinib, or other drugs that target egfr
boolean
C1122962 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0034802 (UMLS CUI [3,3])
Investigational New Drugs
Item
patients must not be receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Illness Serious Treatment required for | Medical condition Treatment required for | Heart Diseases Unstable | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease Uncontrolled
Item
other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
C0036572 (UMLS CUI [8])
C0009450 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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