ID

42142

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01251796

Palabras clave

  1. 29/5/16 29/5/16 -
  2. 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
Subido en

13 de abril de 2021

DOI

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Licencia

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
Descripción

Inclusion Criteria

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

informed consent

Tipo de datos

boolean

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

non-small-cell lung cancer

Tipo de datos

boolean

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

chemotherapy regimen

Tipo de datos

boolean

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

ecog

Tipo de datos

boolean

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

life expectancy

Tipo de datos

boolean

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

CYP2 gene

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332828
Exclusion Criteria
Descripción

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
Descripción

egfr-tki

Tipo de datos

boolean

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

cancer surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920424
active double cancer
Descripción

Multiple malignancy

Tipo de datos

boolean

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

brain metastases

Tipo de datos

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)
Descripción

intercurrent illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3640977
pregnant or lactating
Descripción

pregnant or lactating

Tipo de datos

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
Descripción

contraceptive measures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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