ID

42142

Beschrijving

A Study of ARQ 197 in Combination With Erlotinib; ODM derived from: https://clinicaltrials.gov/show/NCT01251796

Link

https://clinicaltrials.gov/show/NCT01251796

Trefwoorden

  1. 29-05-16 29-05-16 -
  2. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
Geüploaded op

13 april 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
voluntary written informed consent for study participation must be obtained
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
Beschrijving

non-small-cell lung cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen)
Beschrijving

chemotherapy regimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1443775
ecog ps of 0 or 1
Beschrijving

ecog

Datatype

boolean

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

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
poor metabolizers as defined by cyp2c19 genotype
Beschrijving

CYP2 gene

Datatype

boolean

Alias
UMLS CUI [1]
C1332828
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
anti-cancer chemotherapy, anti-cancer therapy with egfr-tki, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to arq 197 dose
Beschrijving

egfr-tki

Datatype

boolean

surgery for cancer within 28 days prior to arq 197 dose
Beschrijving

cancer surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0920424
active double cancer
Beschrijving

Multiple malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0346429
known symptomatic brain metastases
Beschrijving

brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
Beschrijving

intercurrent illness

Datatype

boolean

Alias
UMLS CUI [1]
C3640977
pregnant or lactating
Beschrijving

pregnant or lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who wish to have a child and who would not agree to use contraceptive measures
Beschrijving

contraceptive measures

Datatype

boolean

Alias
UMLS CUI [1]
C0700589

Similar models

Eligibility Advanced/Recurrent Non-small-cell Lung Cancer NCT01251796

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
voluntary written informed consent for study participation must be obtained
boolean
C0021430 (UMLS CUI [1])
non-small-cell lung cancer
Item
a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
boolean
C0007131 (UMLS CUI [1])
chemotherapy regimen
Item
history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen)
boolean
C0392920 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
ecog
Item
ecog ps of 0 or 1
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of ≥3 months
boolean
C0023671 (UMLS CUI [1])
CYP2 gene
Item
poor metabolizers as defined by cyp2c19 genotype
boolean
C1332828 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
egfr-tki
Item
anti-cancer chemotherapy, anti-cancer therapy with egfr-tki, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to arq 197 dose
boolean
cancer surgery
Item
surgery for cancer within 28 days prior to arq 197 dose
boolean
C0920424 (UMLS CUI [1])
Multiple malignancy
Item
active double cancer
boolean
C0346429 (UMLS CUI [1])
brain metastases
Item
known symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1])
intercurrent illness
Item
an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
boolean
C3640977 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraceptive measures
Item
subjects who wish to have a child and who would not agree to use contraceptive measures
boolean
C0700589 (UMLS CUI [1])

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