ID

26208

Descripción

APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202); ODM derived from: https://clinicaltrials.gov/show/NCT00657137

Link

https://clinicaltrials.gov/show/NCT00657137

Palabras clave

Versiones (1)
  1. 11/10/17 11/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de octubre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00657137

Inglés

Eligibility Breast Cancer NCT00657137

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (her2/neu+) breast cancer
Descripción

Gender | Locally advanced breast cancer HER2/Neu Positive | Secondary malignant neoplasm of female breast HER2/Neu Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C2348909
UMLS CUI [3,1]
C0346993
UMLS CUI [3,2]
C2348909
have progressed after treatment with chemotherapy including a taxane and trastuzumab
Descripción

Chemotherapy | taxane | trastuzumab | Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0215136
UMLS CUI [3]
C0728747
UMLS CUI [4]
C0242656
must have measurable disease by recist
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
ecog ps of 0,1, or 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
muga scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
Descripción

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
Descripción

Therapeutic radiology procedure | Chemotherapy | Non-Cytotoxic Agent Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C2827065
UMLS CUI [3,2]
C1517586
evidence of new york heart association class iii or greater cardiac disease
Descripción

Heart Disease New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
history of mi, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
Descripción

Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Conduction abnormality Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0085612
UMLS CUI [4,1]
C0232219
UMLS CUI [4,2]
C0231220
history of congenital qt prolongation
Descripción

Prolonged QT interval Congenital

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C1744681
concurrent severe or uncontrolled medical disease
Descripción

Comorbidity Severe | Comorbidity Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
symptomatic central nervous system metastases
Descripción

CNS metastases Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
pregnant or nursing women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-fu, sulfonamides, aspirin, or nsaids
Descripción

Hypersensitivity apricoxib | Hypersensitivity lapatinib | Hypersensitivity capecitabine | Fluorouracil allergy | Allergy to sulfonamides | Aspirin allergy | Non-steroidal anti-inflammatory drug allergy | Intolerance to apricoxib | Intolerance to lapatinib | Intolerance to capecitabine | Intolerance to Fluorouracil | Intolerance to Sulfonamides | Intolerance to Aspirin | Intolerance to NSAIDS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1737955
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1506770
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0671970
UMLS CUI [4]
C0570698
UMLS CUI [5]
C0038757
UMLS CUI [6]
C0004058
UMLS CUI [7]
C0570537
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C1737955
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C1506770
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0671970
UMLS CUI [11,1]
C1744706
UMLS CUI [11,2]
C0016360
UMLS CUI [12,1]
C1744706
UMLS CUI [12,2]
C0038760
UMLS CUI [13,1]
C1744706
UMLS CUI [13,2]
C0004057
UMLS CUI [14,1]
C1744706
UMLS CUI [14,2]
C0003211
severe renal insufficiency
Descripción

Renal Insufficiency Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
history of upper gi bleeding, ulceration, or perforation- concurrent use of potent cyp3a4 inhibitors and cyp3a4 inducers
Descripción

Upper gastrointestinal hemorrhage | Upper gastrointestinal tract Ulceration | UPPER GASTROINTESTINAL PERFORATION | CYP3A4 Inhibitors | CYP3A4 Inducers

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041909
UMLS CUI [2,1]
C1268997
UMLS CUI [2,2]
C3887532
UMLS CUI [3]
C0749862
UMLS CUI [4]
C3850053
UMLS CUI [5]
C3850041
prior treatment with capecitabine
Descripción

capecitabine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0671970
patients on anti-arrhythmic treatment
Descripción

Anti-Arrhythmia Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003195
prior lapatinib therapy
Descripción

lapatinib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1506770
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Similar models

Eligibility Breast Cancer NCT00657137

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Locally advanced breast cancer HER2/Neu Positive | Secondary malignant neoplasm of female breast HER2/Neu Positive
Item
females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (her2/neu+) breast cancer
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3,1])
C2348909 (UMLS CUI [3,2])
Chemotherapy | taxane | trastuzumab | Disease Progression
Item
have progressed after treatment with chemotherapy including a taxane and trastuzumab
boolean
C0392920 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
C0728747 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
Measurable Disease
Item
must have measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog ps of 0,1, or 2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
muga scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Chemotherapy | Non-Cytotoxic Agent Investigational
Item
radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C2827065 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
Heart Disease New York Heart Association Classification
Item
evidence of new york heart association class iii or greater cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Conduction abnormality Symptomatic
Item
history of mi, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C0232219 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Prolonged QT interval Congenital
Item
history of congenital qt prolongation
boolean
C0151878 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
Comorbidity Severe | Comorbidity Uncontrolled
Item
concurrent severe or uncontrolled medical disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
CNS metastases Symptomatic
Item
symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity apricoxib | Hypersensitivity lapatinib | Hypersensitivity capecitabine | Fluorouracil allergy | Allergy to sulfonamides | Aspirin allergy | Non-steroidal anti-inflammatory drug allergy | Intolerance to apricoxib | Intolerance to lapatinib | Intolerance to capecitabine | Intolerance to Fluorouracil | Intolerance to Sulfonamides | Intolerance to Aspirin | Intolerance to NSAIDS
Item
hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-fu, sulfonamides, aspirin, or nsaids
boolean
C0020517 (UMLS CUI [1,1])
C1737955 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1506770 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0671970 (UMLS CUI [3,2])
C0570698 (UMLS CUI [4])
C0038757 (UMLS CUI [5])
C0004058 (UMLS CUI [6])
C0570537 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C1737955 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C1506770 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0671970 (UMLS CUI [10,2])
C1744706 (UMLS CUI [11,1])
C0016360 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0038760 (UMLS CUI [12,2])
C1744706 (UMLS CUI [13,1])
C0004057 (UMLS CUI [13,2])
C1744706 (UMLS CUI [14,1])
C0003211 (UMLS CUI [14,2])
Renal Insufficiency Severe
Item
severe renal insufficiency
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Upper gastrointestinal hemorrhage | Upper gastrointestinal tract Ulceration | UPPER GASTROINTESTINAL PERFORATION | CYP3A4 Inhibitors | CYP3A4 Inducers
Item
history of upper gi bleeding, ulceration, or perforation- concurrent use of potent cyp3a4 inhibitors and cyp3a4 inducers
boolean
C0041909 (UMLS CUI [1])
C1268997 (UMLS CUI [2,1])
C3887532 (UMLS CUI [2,2])
C0749862 (UMLS CUI [3])
C3850053 (UMLS CUI [4])
C3850041 (UMLS CUI [5])
capecitabine
Item
prior treatment with capecitabine
boolean
C0671970 (UMLS CUI [1])
Anti-Arrhythmia Agents
Item
patients on anti-arrhythmic treatment
boolean
C0003195 (UMLS CUI [1])
lapatinib
Item
prior lapatinib therapy
boolean
C1506770 (UMLS CUI [1])
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