ID

22211

Beschreibung

Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00352950

Link

https://clinicaltrials.gov/show/NCT00352950

Stichworte

Versionen (1)
  1. 23.05.17 23.05.17 -
Hochgeladen am

23. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Oncology NCT00352950

Englisch

Eligibility Oncology NCT00352950

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Oncology NCT00352950
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically-confirmed diagnosis of stage iiib or iv non-small cell lung cancer
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
received only one prior treatment (not including radiation)
Beschreibung

Prior Therapy Single | Therapeutic radiology procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
measurable disease per response evaluation criteria in solid tumors group (recist) guidelines
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
life expectancy of ≥ 4 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal and hepatic function
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
serum-fasting cholesterol ≤ 300 mg/dl serum-fasting triglycerides ≤ 2.5 x uln exclusion criteria:
Beschreibung

Fasting cholesterol level | Serum fasting triglyceride measurement | Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1282513
UMLS CUI [2]
C0582824
UMLS CUI [3]
C0680251
brain metastases requiring treatment
Beschreibung

Metastatic malignant neoplasm to brain Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332121
history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
Beschreibung

Pneumonia, Interstitial | Pulmonary Fibrosis | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of

Datentyp

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
UMLS CUI [3,1]
C0206061
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C0034069
UMLS CUI [4,2]
C0332120
systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
Beschreibung

Systemic Chemotherapy | Therapeutic radiology procedure Systemic | Hormone Therapy Systemic | Immunotherapy Systemic

Datentyp

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0205373
prior epidermal growth factor receptor targeting agents with the exception of the small molecule egfr tyrosine kinase inhibitors
Beschreibung

Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor | Small Molecule Epidermal growth factor receptor inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0034802
UMLS CUI [2,1]
C1328819
UMLS CUI [2,2]
C1443775
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
Beschreibung

Cancer treatment | Investigational New Drugs | Small Molecule Against Neoplasms | Biological Products Serum Half-Life Short | Proteins Serum Half-Life Long | Antibodies Serum Half-Life Long

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0027651
UMLS CUI [4,1]
C0005522
UMLS CUI [4,2]
C0229671
UMLS CUI [4,3]
C0018517
UMLS CUI [4,4]
C1806781
UMLS CUI [5,1]
C0033684
UMLS CUI [5,2]
C0229671
UMLS CUI [5,3]
C0018517
UMLS CUI [5,4]
C0205166
UMLS CUI [6,1]
C0003241
UMLS CUI [6,2]
C0229671
UMLS CUI [6,3]
C0018517
UMLS CUI [6,4]
C0205166
prior therapy with sirolimus, sirolimus analogs
Beschreibung

Sirolimus | Sirolimus Analogs

Datentyp

boolean

Alias
UMLS CUI [1]
C0072980
UMLS CUI [2,1]
C0072980
UMLS CUI [2,2]
C0243071
immunosuppressive agents within 28 days before enrollment
Beschreibung

Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
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Ähnliche Modelle

Eligibility Oncology NCT00352950

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Oncology NCT00352950
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically- or cytologically-confirmed diagnosis of stage iiib or iv non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prior Therapy Single | Therapeutic radiology procedure Absent
Item
received only one prior treatment (not including radiation)
boolean
C1514463 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease per response evaluation criteria in solid tumors group (recist) guidelines
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥ 4 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Fasting cholesterol level | Serum fasting triglyceride measurement | Exclusion Criteria
Item
serum-fasting cholesterol ≤ 300 mg/dl serum-fasting triglycerides ≤ 2.5 x uln exclusion criteria:
boolean
C1282513 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
C0680251 (UMLS CUI [3])
Metastatic malignant neoplasm to brain Treatment required for
Item
brain metastases requiring treatment
boolean
C0220650 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Pneumonia, Interstitial | Pulmonary Fibrosis | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of
Item
history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
C0206061 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C0034069 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
Systemic Chemotherapy | Therapeutic radiology procedure Systemic | Hormone Therapy Systemic | Immunotherapy Systemic
Item
systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
boolean
C1883256 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor | Small Molecule Epidermal growth factor receptor inhibitor
Item
prior epidermal growth factor receptor targeting agents with the exception of the small molecule egfr tyrosine kinase inhibitors
boolean
C0013227 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C1328819 (UMLS CUI [2,1])
C1443775 (UMLS CUI [2,2])
Cancer treatment | Investigational New Drugs | Small Molecule Against Neoplasms | Biological Products Serum Half-Life Short | Proteins Serum Half-Life Long | Antibodies Serum Half-Life Long
Item
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0005522 (UMLS CUI [4,1])
C0229671 (UMLS CUI [4,2])
C0018517 (UMLS CUI [4,3])
C1806781 (UMLS CUI [4,4])
C0033684 (UMLS CUI [5,1])
C0229671 (UMLS CUI [5,2])
C0018517 (UMLS CUI [5,3])
C0205166 (UMLS CUI [5,4])
C0003241 (UMLS CUI [6,1])
C0229671 (UMLS CUI [6,2])
C0018517 (UMLS CUI [6,3])
C0205166 (UMLS CUI [6,4])
Sirolimus | Sirolimus Analogs
Item
prior therapy with sirolimus, sirolimus analogs
boolean
C0072980 (UMLS CUI [1])
C0072980 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
Immunosuppressive Agents
Item
immunosuppressive agents within 28 days before enrollment
boolean
C0021081 (UMLS CUI [1])
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