ID

31111

Beskrivning

A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00534027

Länk

https://clinicaltrials.gov/show/NCT00534027

Nyckelord

Versioner (1)
  1. 2018-07-20 2018-07-20 -
Rättsinnehavare

See clinicaltrials.gov

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20 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00534027

Engelsk

Eligibility Non-Small Cell Lung Cancer NCT00534027

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease related
Beskrivning

Disease Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
histologically or cytologically confirmed non-small cell lung cancer.
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
subjects must have advanced non-small cell lung cancer defined as stage iiib with malignant pleural effusion or stage iv or recurrent disease.
Beskrivning

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Pleural Effusion, Malignant | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3]
C0277556
planning to receive up to 6 cycles of chemotherapy
Beskrivning

Chemotherapy cycle Quantity Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301732
eastern cooperative oncology group (ecog) score of 0 or 1 demographic
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
men or women > 18 years of age ethical
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate hematological, renal, hepatic and coagulation function general
Beskrivning

Hematologic function | Renal function | Liver function | Coagulation function analysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C3516400
plan to begin protocol specific therapy < 7 days after enrollment/randomization
Beskrivning

Therapeutic procedure Study Protocol Specific

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
disease related
Beskrivning

Disease Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
untreated or symptomatic central nervous system metastases. subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
Beskrivning

CNS metastases untreated | CNS metastases Symptomatic | Metastatic malignant neoplasm to brain Eligible | Relationship Definitive Treatment | Relationship Operative Surgical Procedures | Relationship Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1548635
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C2986592
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0543467
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C1522449
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C1444662
prior chemotherapy as follows:
Beskrivning

Prior Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
any prior chemotherapy for advanced non-small cell lung cancer
Beskrivning

Prior Chemotherapy Non-Small Cell Lung Carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
Beskrivning

Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0683607
any prior chemoradiation.
Beskrivning

Chemoradiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0436307
central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
Beskrivning

Radiotherapy to thorax | Radiotherapy to lesion of peripheral nerve

Datatyp

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2]
C0394630
other abnormal medical conditions
Beskrivning

Other medical condition Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205161
documented myocardial infarction or unstable/uncontrolled cardiac condition
Beskrivning

Myocardial Infarction | Condition cardiac Unstable | Condition cardiac Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C0443343
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0205318
history of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
Beskrivning

Arterial thrombosis | Pulmonary Embolism | Deep Vein Thrombosis | Hemorrhagic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0151942
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0149871
UMLS CUI [4]
C0019087
major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
Beskrivning

Major surgery | Major surgery Previous Recovery Lacking | Minor Surgical Procedures | Minor Surgical Procedures Previous Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C2004454
UMLS CUI [2,4]
C0332268
UMLS CUI [3]
C0038904
UMLS CUI [4,1]
C0038904
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C2004454
UMLS CUI [4,4]
C0332268
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00534027

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Disease Related
Item
disease related
boolean
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed non-small cell lung cancer.
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Pleural Effusion, Malignant | Recurrent disease
Item
subjects must have advanced non-small cell lung cancer defined as stage iiib with malignant pleural effusion or stage iv or recurrent disease.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0080032 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Chemotherapy cycle Quantity Planned
Item
planning to receive up to 6 cycles of chemotherapy
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0 or 1 demographic
boolean
C1520224 (UMLS CUI [1])
Age
Item
men or women > 18 years of age ethical
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Coagulation function analysis
Item
adequate hematological, renal, hepatic and coagulation function general
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C3516400 (UMLS CUI [4])
Therapeutic procedure Study Protocol Specific
Item
plan to begin protocol specific therapy < 7 days after enrollment/randomization
boolean
C0087111 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Disease Related
Item
disease related
boolean
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
CNS metastases untreated | CNS metastases Symptomatic | Metastatic malignant neoplasm to brain Eligible | Relationship Definitive Treatment | Relationship Operative Surgical Procedures | Relationship Therapeutic radiology procedure | Adrenal Cortex Hormones Discontinued
Item
untreated or symptomatic central nervous system metastases. subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1548635 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C2986592 (UMLS CUI [4,2])
C0439849 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0439849 (UMLS CUI [6,1])
C1522449 (UMLS CUI [6,2])
C0001617 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
Prior Chemotherapy
Item
prior chemotherapy as follows:
boolean
C1514457 (UMLS CUI [1])
Prior Chemotherapy Non-Small Cell Lung Carcinoma Advanced
Item
any prior chemotherapy for advanced non-small cell lung cancer
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma
Item
any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
boolean
C0085533 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
Chemoradiotherapy
Item
any prior chemoradiation.
boolean
C0436307 (UMLS CUI [1])
Radiotherapy to thorax | Radiotherapy to lesion of peripheral nerve
Item
central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
boolean
C4038705 (UMLS CUI [1])
C0394630 (UMLS CUI [2])
Other medical condition Abnormal
Item
other abnormal medical conditions
boolean
C3843040 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Myocardial Infarction | Condition cardiac Unstable | Condition cardiac Uncontrolled
Item
documented myocardial infarction or unstable/uncontrolled cardiac condition
boolean
C0027051 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Arterial thrombosis | Pulmonary Embolism | Deep Vein Thrombosis | Hemorrhagic Disorders
Item
history of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
boolean
C0151942 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0149871 (UMLS CUI [3])
C0019087 (UMLS CUI [4])
Major surgery | Major surgery Previous Recovery Lacking | Minor Surgical Procedures | Minor Surgical Procedures Previous Recovery Lacking
Item
major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C2004454 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
C0038904 (UMLS CUI [3])
C0038904 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2004454 (UMLS CUI [4,3])
C0332268 (UMLS CUI [4,4])
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