ID

24772

Description

Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00569114

Link

https://clinicaltrials.gov/show/NCT00569114

Keywords

Versions (1)
  1. 8/16/17 8/16/17 -
Uploaded on

August 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00569114

English

Eligibility Non-small Cell Lung Cancer NCT00569114

1 forms  
Criteria
Description

Criteria

histogically or pathologically determined relapsed/recurrent stage iiib (plueral effusion) or iv nsclc.
Description

Non-small cell lung cancer recurrent TNM clinical staging | Pleural effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0278517
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
measurable or evaluable disease as defined by recist
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
Description

Chemotherapy Regimen Quantity failed | Chemotherapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1705116
ecog perfromance status of 0,1, or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
exclusion criteria (include but are not limited to):
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
radiation therapy (excluding cns therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
Description

Therapeutic radiology procedure | Exception Therapeutic procedure Central Nervous System | Chemotherapy | Investigational New Drugs Non-Cytotoxic | Adrenal Cortex Hormones High dose | Adverse effects of medical drugs Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C3714787
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C2827065
UMLS CUI [5,1]
C0001617
UMLS CUI [5,2]
C0444956
UMLS CUI [6,1]
C0810090
UMLS CUI [6,2]
C2004454
UMLS CUI [6,3]
C0332268
evidence of new york heart associatation class iii or greater cardiac disease.
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
history of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
Description

Myocardial Infarction | Cerebrovascular accident | Intervention Cardiovascular

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C3887460
patients on anti-platlet drugs or anticoagulants such as placix and coumadin.
Description

Antiplatelet Agents | Anticoagulants | Plavix | Coumadin

Data type

boolean

Alias
UMLS CUI [1]
C0085826
UMLS CUI [2]
C0003280
UMLS CUI [3]
C0633084
UMLS CUI [4]
C0699129
systemic central nervous system metastases. the patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
Description

CNS metastases Systemic | Stable status Post Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1444662
pregnant or nursing women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who are primarily refactory to erlotinib.
Description

Erlotinib Refractory Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C1135135
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0205225
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00569114

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-small cell lung cancer recurrent TNM clinical staging | Pleural effusion
Item
histogically or pathologically determined relapsed/recurrent stage iiib (plueral effusion) or iv nsclc.
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease as defined by recist
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Chemotherapy Regimen Quantity failed | Chemotherapy Refused
Item
must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
ECOG performance status
Item
ecog perfromance status of 0,1, or 2.
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria (include but are not limited to):
boolean
C0680251 (UMLS CUI [1])
Therapeutic radiology procedure | Exception Therapeutic procedure Central Nervous System | Chemotherapy | Investigational New Drugs Non-Cytotoxic | Adrenal Cortex Hormones High dose | Adverse effects of medical drugs Recovery Lacking
Item
radiation therapy (excluding cns therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C3714787 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
C0013230 (UMLS CUI [4,1])
C2827065 (UMLS CUI [4,2])
C0001617 (UMLS CUI [5,1])
C0444956 (UMLS CUI [5,2])
C0810090 (UMLS CUI [6,1])
C2004454 (UMLS CUI [6,2])
C0332268 (UMLS CUI [6,3])
Heart Disease New York Heart Association Classification
Item
evidence of new york heart associatation class iii or greater cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident | Intervention Cardiovascular
Item
history of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C3887460 (UMLS CUI [3,2])
Antiplatelet Agents | Anticoagulants | Plavix | Coumadin
Item
patients on anti-platlet drugs or anticoagulants such as placix and coumadin.
boolean
C0085826 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
C0633084 (UMLS CUI [3])
C0699129 (UMLS CUI [4])
CNS metastases Systemic | Stable status Post Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued
Item
systemic central nervous system metastases. the patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
boolean
C0686377 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Erlotinib Refractory Primary
Item
patients who are primarily refactory to erlotinib.
boolean
C1135135 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
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