ID

31079

Beschreibung

Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00517790

Link

https://clinicaltrials.gov/show/NCT00517790

Stichworte

Versionen (1)
  1. 19.07.18 19.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. Juli 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT00517790

Englisch

Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT00517790

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must be histologically or cytologically diagnosed with advanced or metastatic nsclc
Beschreibung

Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0278987
subjects must have at least one lesion measurable by ct scan as defined by recist
Beschreibung

Measurable lesion Quantity CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0040405
the measurable lesion may have not received radiation therapy
Beschreibung

Therapeutic radiology procedure Absent Measurable lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1513041
subject has an eastern cooperative oncology group (ecog) performance status of 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic nsclc. in addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for nsclc
Beschreibung

Line Systemic therapy Quantity | Therapeutic procedure Quantity Non-Small Cell Lung Carcinoma Advanced | Therapeutic procedure Quantity Non-small cell lung cancer metastatic | Chemotherapy Neoadjuvant Systemic Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Systemic Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0007131
UMLS CUI [2,4]
C0205179
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0278987
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C0205373
UMLS CUI [4,4]
C0007131
UMLS CUI [5,1]
C0085533
UMLS CUI [5,2]
C0205373
UMLS CUI [5,3]
C0007131
adequate organ function
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has received targeted vegf/pdgf tki (tyrosine kinase inhibitor) therapy. prior avastin is allowed.
Beschreibung

VEGFR Tyrosine Kinase Inhibitor Targeted Therapy | PDGF Tyrosine kinase inhibitor Targeted Therapy | Avastin allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2985521
UMLS CUI [1,2]
C2985566
UMLS CUI [2,1]
C0032200
UMLS CUI [2,2]
C1268567
UMLS CUI [2,3]
C2985566
UMLS CUI [3,1]
C1135130
UMLS CUI [3,2]
C0683607
subject has untreated brain or meningeal metastases.
Beschreibung

Metastatic malignant neoplasm to brain untreated | Meningeal Carcinomatosis untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220654
UMLS CUI [2,2]
C0332155
history of greater than 10% weight loss
Beschreibung

Weight decreased Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
subject has clinically relevant hemoptysis
Beschreibung

Hemoptysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019079
the subject has proteinuria ctc grade > 1
Beschreibung

Proteinuria CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033687
UMLS CUI [1,2]
C1516728
the subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmhg or systolic blood pressure > 150 mmhg. subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
Beschreibung

Uncontrolled hypertension Symptomatic | Uncontrolled hypertension Persistent | Diastolic blood pressure | Systolic Pressure | Control of blood pressure Associated with Intervention | Control of blood pressure Without Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205322
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0871470
UMLS CUI [5,1]
C1753303
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0184661
UMLS CUI [6,1]
C1753303
UMLS CUI [6,2]
C0332288
UMLS CUI [6,3]
C0184661
the subject has a documented left ventricular ejection fraction < 50%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
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Ähnliche Modelle

Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT00517790

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic
Item
subject must be histologically or cytologically diagnosed with advanced or metastatic nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2])
Measurable lesion Quantity CT scan
Item
subjects must have at least one lesion measurable by ct scan as defined by recist
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Therapeutic radiology procedure Absent Measurable lesion
Item
the measurable lesion may have not received radiation therapy
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
ECOG performance status
Item
subject has an eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Line Systemic therapy Quantity | Therapeutic procedure Quantity Non-Small Cell Lung Carcinoma Advanced | Therapeutic procedure Quantity Non-small cell lung cancer metastatic | Chemotherapy Neoadjuvant Systemic Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Systemic Non-Small Cell Lung Carcinoma
Item
subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic nsclc. in addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for nsclc
boolean
C4524693 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0205179 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0278987 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C0205373 (UMLS CUI [4,3])
C0007131 (UMLS CUI [4,4])
C0085533 (UMLS CUI [5,1])
C0205373 (UMLS CUI [5,2])
C0007131 (UMLS CUI [5,3])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
VEGFR Tyrosine Kinase Inhibitor Targeted Therapy | PDGF Tyrosine kinase inhibitor Targeted Therapy | Avastin allowed
Item
subject has received targeted vegf/pdgf tki (tyrosine kinase inhibitor) therapy. prior avastin is allowed.
boolean
C2985521 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0032200 (UMLS CUI [2,1])
C1268567 (UMLS CUI [2,2])
C2985566 (UMLS CUI [2,3])
C1135130 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain untreated | Meningeal Carcinomatosis untreated
Item
subject has untreated brain or meningeal metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220654 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Weight decreased Percentage
Item
history of greater than 10% weight loss
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Hemoptysis
Item
subject has clinically relevant hemoptysis
boolean
C0019079 (UMLS CUI [1])
Proteinuria CTCAE Grades
Item
the subject has proteinuria ctc grade > 1
boolean
C0033687 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Uncontrolled hypertension Symptomatic | Uncontrolled hypertension Persistent | Diastolic blood pressure | Systolic Pressure | Control of blood pressure Associated with Intervention | Control of blood pressure Without Intervention
Item
the subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmhg or systolic blood pressure > 150 mmhg. subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
boolean
C1868885 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
C1753303 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0184661 (UMLS CUI [5,3])
C1753303 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0184661 (UMLS CUI [6,3])
Left ventricular ejection fraction
Item
the subject has a documented left ventricular ejection fraction < 50%
boolean
C0428772 (UMLS CUI [1])
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