ID

19749

Beschrijving

Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00266877

Link

https://clinicaltrials.gov/show/NCT00266877

Trefwoorden

Versies (1)
  1. 26-01-17 26-01-17 -
Geüploaded op

26 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00266877

Engels

Eligibility Carcinoma, Non-Small-Cell Lung NCT00266877

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of nsclc and current stage iiib (with pleural effusion) or iv, not curable with conventional therapy. for arm c, less than or equal to 20 pack-years smoking history and current non smoker. a pack year = number of packs of cigarettes smoked per day x years smoked.
Beschrijving

Non-Small Cell Lung Carcinoma Pleural effusion TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Conventional Treatment Cure Unsuccessful | smoking cigarettes: ____ pack-years history | Non-smoker

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0032227
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C2945704
UMLS CUI [3,2]
C1880198
UMLS CUI [3,3]
C1272705
UMLS CUI [4]
C2230126
UMLS CUI [5]
C0337672
progression following at least 12 weeks of treatment with tarceva or iressa. (arms a and b only)
Beschrijving

Tarceva | Iressa | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C1135136
UMLS CUI [2]
C0919281
UMLS CUI [3]
C0242656
ecog (eastern cooperative oncology group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
tumor sample available and adequate for analysis.
Beschrijving

Tumor tissue sample Available Analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0002778
at least one measurable target lesion.
Beschrijving

Target Lesion Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
adequate cardiac, kidney, and liver function
Beschrijving

Cardiac function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
adequate blood counts
Beschrijving

Blood Cell Count

Datatype

boolean

Alias
UMLS CUI [1]
C0005771
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
Beschrijving

Cytotoxic Chemotherapy Quantity Recurrent disease | Cytotoxic Chemotherapy Quantity Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
significant cardiac disease or dysfunction.
Beschrijving

Heart Disease Significant | Cardiac dysfunction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C3277906
prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.
Beschrijving

Anthracyclines Cumulative Dose Amount

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C1265611
active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
Beschrijving

CNS metastases Symptoms Clinical | CNS metastases Growth Progressive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0220844
UMLS CUI [2,3]
C0205329
use of tarceva or iressa within 14 days of treatment day 1 (arms a and b only).
Beschrijving

Tarceva | Iressa

Datatype

boolean

Alias
UMLS CUI [1]
C1135136
UMLS CUI [2]
C0919281
major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
Beschrijving

major surgery | Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs | cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0013230
UMLS CUI [5]
C0920425
significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
Beschrijving

Gastrointestinal Disease chronic significant | Gastrointestinal Disease Recent | Diarrhea symptoms major

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0011991
UMLS CUI [3,2]
C0205164
inability or unwillingness to swallow hki-272 capsules.
Beschrijving

Able to swallow HKI 272 capsules | HKI 272 capsules Swallowing Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C1454298
UMLS CUI [1,3]
C0006935
UMLS CUI [2,1]
C1454298
UMLS CUI [2,2]
C0006935
UMLS CUI [2,3]
C0740170
UMLS CUI [2,4]
C0558080
pregnant or breastfeeding women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00266877

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Pleural effusion TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Conventional Treatment Cure Unsuccessful | smoking cigarettes: ____ pack-years history | Non-smoker
Item
pathologic diagnosis of nsclc and current stage iiib (with pleural effusion) or iv, not curable with conventional therapy. for arm c, less than or equal to 20 pack-years smoking history and current non smoker. a pack year = number of packs of cigarettes smoked per day x years smoked.
boolean
C0007131 (UMLS CUI [1,1])
C0032227 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C2945704 (UMLS CUI [3,1])
C1880198 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C2230126 (UMLS CUI [4])
C0337672 (UMLS CUI [5])
Tarceva | Iressa | Disease Progression
Item
progression following at least 12 weeks of treatment with tarceva or iressa. (arms a and b only)
boolean
C1135136 (UMLS CUI [1])
C0919281 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
ECOG performance status
Item
ecog (eastern cooperative oncology group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
boolean
C1520224 (UMLS CUI [1])
Tumor tissue sample Available Analysis
Item
tumor sample available and adequate for analysis.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
Target Lesion Measurable
Item
at least one measurable target lesion.
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Cardiac function | Renal function | Liver function
Item
adequate cardiac, kidney, and liver function
boolean
C0232164 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Blood Cell Count
Item
adequate blood counts
boolean
C0005771 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy Quantity Recurrent disease | Cytotoxic Chemotherapy Quantity Neoplasm Metastasis
Item
more than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Heart Disease Significant | Cardiac dysfunction
Item
significant cardiac disease or dysfunction.
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3277906 (UMLS CUI [2])
Anthracyclines Cumulative Dose Amount
Item
prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.
boolean
C0282564 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
CNS metastases Symptoms Clinical | CNS metastases Growth Progressive
Item
active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
boolean
C0686377 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0686377 (UMLS CUI [2,1])
C0220844 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
Tarceva | Iressa
Item
use of tarceva or iressa within 14 days of treatment day 1 (arms a and b only).
boolean
C1135136 (UMLS CUI [1])
C0919281 (UMLS CUI [2])
major surgery | Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs | cancer treatment
Item
major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
boolean
C0679637 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
C0920425 (UMLS CUI [5])
Gastrointestinal Disease chronic significant | Gastrointestinal Disease Recent | Diarrhea symptoms major
Item
significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
boolean
C0017178 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0011991 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Able to swallow HKI 272 capsules | HKI 272 capsules Swallowing Unwilling
Item
inability or unwillingness to swallow hki-272 capsules.
boolean
C2712086 (UMLS CUI [1,1])
C1454298 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1454298 (UMLS CUI [2,1])
C0006935 (UMLS CUI [2,2])
C0740170 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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