ID

26208

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-10-17 11-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 oktober 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00657137

Engels

Eligibility Breast Cancer NCT00657137

1 Formulieren  
Inclusion Criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

Chemotherapy | taxane | trastuzumab | Disease Progression

Datatype

boolean

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

Measurable Disease

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

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

Datatype

boolean

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

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
Beschrijving

Therapeutic radiology procedure | Chemotherapy | Non-Cytotoxic Agent Investigational

Datatype

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
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

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

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

Datatype

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
Beschrijving

Prolonged QT interval Congenital

Datatype

boolean

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

Comorbidity Severe | Comorbidity Uncontrolled

Datatype

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
Beschrijving

CNS metastases Symptomatic

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

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

Datatype

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
Beschrijving

Renal Insufficiency Severe

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

capecitabine

Datatype

boolean

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

Anti-Arrhythmia Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003195
prior lapatinib therapy
Beschrijving

lapatinib

Datatype

boolean

Alias
UMLS CUI [1]
C1506770
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00657137

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial