ID

31156

Beschreibung

A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib); ODM derived from: https://clinicaltrials.gov/show/NCT00854308

Link

https://clinicaltrials.gov/show/NCT00854308

Stichworte

Versionen (1)
  1. 23.07.18 23.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. Juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00854308

Englisch

Eligibility Non-Small Cell Lung Cancer NCT00854308

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must meet the following criteria for study entry:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
histologically confirmed nsclc
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
availability of a tumor specimen
Beschreibung

Availability of Tumor tissue sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
recurrent or progressive disease following at least one chemo containing regimen for stage iiib/iv disease
Beschreibung

Recurrent disease | Progressive Disease | Chemotherapy Quantity Disease TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0012634
UMLS CUI [3,4]
C3258246
measurable disease in accordance with response evaluation criteria in solid tumors (recist)
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
at least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron emission tomography (fdg-pet) scan that is also a target lesion on computed tomography (ct) according to recist
Beschreibung

Measurable lesion Quantity FDG-PET Pretreatment | Target Lesion CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3641247
UMLS CUI [1,4]
C3539075
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0040405
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two prior treatments for stage iiib/iv
Beschreibung

Prior Therapy Quantity TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3258246
more than 30 days of exposure to an investigational or marketed agent that can act by egfr inhibition, or a known epidermal growth factor receptor (egfr)-related toxicity resulting in dose modifications
Beschreibung

Exposure to EGFR inhibitor | Toxicity EGFR Related | Toxicity Resulting in Dose Modification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1443775
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0034802
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C1707811
chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
Beschreibung

Chemotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0013230
untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (cns) metastasis
Beschreibung

CNS metastases untreated | CNS metastases Progressive | CNS metastases Requirement Control Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0243148
UMLS CUI [3,4]
C0231220
UMLS CUI [4,1]
C0686377
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0003286
UMLS CUI [5,1]
C0686377
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0001617
history of serious systemic disease within the past 6 months prior to randomization
Beschreibung

Systemic disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
uncontrolled diabetes
Beschreibung

Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
major surgical procedure or significant traumatic injury within 28 days prior to randomization
Beschreibung

Major surgery | Traumatic injury

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
anticipation of need for a major surgical procedure during the course of the study
Beschreibung

Anticipation Patient need for Major surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679106
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0679637
local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to grade ii or less prior to randomization
Beschreibung

Palliative course of radiotherapy Local | Adverse effect of radiation therapy Persistent | Absence Resolution CTCAE grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0392615
UMLS CUI [2,2]
C0205322
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1514893
UMLS CUI [3,3]
C1516728
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Beschreibung

Hypercalcemia Symptomatic | Requirement Diphosphonates

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0012544
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Ähnliche Modelle

Eligibility Non-Small Cell Lung Cancer NCT00854308

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must meet the following criteria for study entry:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma
Item
histologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Availability of Tumor tissue sample
Item
availability of a tumor specimen
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Recurrent disease | Progressive Disease | Chemotherapy Quantity Disease TNM clinical staging
Item
recurrent or progressive disease following at least one chemo containing regimen for stage iiib/iv disease
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
Measurable Disease
Item
measurable disease in accordance with response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
Measurable lesion Quantity FDG-PET Pretreatment | Target Lesion CT
Item
at least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron emission tomography (fdg-pet) scan that is also a target lesion on computed tomography (ct) according to recist
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
C3539075 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Quantity TNM clinical staging
Item
more than two prior treatments for stage iiib/iv
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Exposure to EGFR inhibitor | Toxicity EGFR Related | Toxicity Resulting in Dose Modification
Item
more than 30 days of exposure to an investigational or marketed agent that can act by egfr inhibition, or a known epidermal growth factor receptor (egfr)-related toxicity resulting in dose modifications
boolean
C0332157 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0034802 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C1707811 (UMLS CUI [3,3])
Chemotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs
Item
chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
CNS metastases untreated | CNS metastases Progressive | CNS metastases Requirement Control Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Adrenal Cortex Hormones
Item
untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (cns) metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0243148 (UMLS CUI [3,3])
C0231220 (UMLS CUI [3,4])
C0686377 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003286 (UMLS CUI [4,3])
C0686377 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0001617 (UMLS CUI [5,3])
Systemic disease Serious
Item
history of serious systemic disease within the past 6 months prior to randomization
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Major surgery | Traumatic injury
Item
major surgical procedure or significant traumatic injury within 28 days prior to randomization
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
Anticipation Patient need for Major surgery
Item
anticipation of need for a major surgical procedure during the course of the study
boolean
C0679106 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0679637 (UMLS CUI [1,3])
Palliative course of radiotherapy Local | Adverse effect of radiation therapy Persistent | Absence Resolution CTCAE grades
Item
local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to grade ii or less prior to randomization
boolean
C0475092 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0392615 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Hypercalcemia Symptomatic | Requirement Diphosphonates
Item
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
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