ID

26562

Beschrijving

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00741260

Link

https://clinicaltrials.gov/show/NCT00741260

Trefwoorden

Versies (1)
  1. 19-10-17 19-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 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 NCT00741260

Engels

Eligibility Breast Cancer NCT00741260

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1: confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
Beschrijving

Solid tumour incurable | Treatment option | Neratinib | Capecitabine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0175969
UMLS CUI [2]
C0683525
UMLS CUI [3]
C2713008
UMLS CUI [4]
C0671970
part 2: confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
Beschrijving

Secondary malignant neoplasm of female breast | Locally advanced breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C3495949
part 2: erbb-2 gene amplified tumor (fish or cish) or erbb-2 overexpression (ihc 3+, or ihc2+ with fish or cish confirmation), based on local testing, or based on centralized fish testing prior to day 1.
Beschrijving

HER2 gene amplification Neoplasm FISH | HER2 gene amplification Neoplasm CISH | ERBB2 Protein Overexpression Immunohistochemistry Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0162789
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C1516514
UMLS CUI [3,1]
C1515560
UMLS CUI [3,2]
C0021044
UMLS CUI [3,3]
C1514241
part 2: disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (prior adjuvant trastuzumab is allowed but not required). a 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
Beschrijving

Disease Progression | trastuzumab | Therapeutic procedure Quantity Secondary malignant neoplasm of female breast | Therapeutic procedure Quantity Locally advanced breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0728747
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0346993
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C3495949
prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
Beschrijving

Taxane | Neoadjuvant Therapy | Adjuvant therapy | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0215136
UMLS CUI [2]
C0600558
UMLS CUI [3]
C0677850
UMLS CUI [4]
C3495949
UMLS CUI [5]
C0346993
parts 1+2: at least 1 measurable lesion as defined by recist criteria.
Beschrijving

Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
parts 1+2: lvef within institutional range of normal as measured by multi-gated acquisition (muga) or echocardiogram (echo).
Beschrijving

Left ventricular ejection fraction MUGA | 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
part 2: prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbb-2 targeted agents except trastuzumab. treatment with erbb-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
Beschrijving

capecitabine | lapatinib | Pharmaceutical Preparations Targeting ERBB2 | Exception Trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0671970
UMLS CUI [2]
C1506770
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0242957
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0728747
part 2: prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines.
Beschrijving

Anthracyclines | Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracyclines Dose Equivalent

Datatype

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C2986497
UMLS CUI [3,1]
C0014582
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0282564
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205163
parts 1+2: subjects with bone as the only site of disease.
Beschrijving

Disease Bone Site only

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262950
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0205171
parts 1+2: active uncontrolled or symptomatic central nervous system (cns) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. subjects with a history of cns metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
Beschrijving

CNS metastases Uncontrolled | CNS metastases Symptomatic | Symptoms Clinical | Cerebral Edema | CNS metastases Growth Progressive | Definitive Treatment CNS metastases allowed | Definitive Treatment Compression of spinal cord allowed | Anticonvulsants Discontinued | Steroids Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0205210
UMLS CUI [4]
C0006114
UMLS CUI [5,1]
C0686377
UMLS CUI [5,2]
C2911660
UMLS CUI [5,3]
C0205329
UMLS CUI [6,1]
C2986592
UMLS CUI [6,2]
C0686377
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C2986592
UMLS CUI [7,2]
C0037926
UMLS CUI [7,3]
C0683607
UMLS CUI [8,1]
C0003286
UMLS CUI [8,2]
C1444662
UMLS CUI [9,1]
C0038317
UMLS CUI [9,2]
C1444662
parts 1+2: any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
Beschrijving

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00741260

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Solid tumour incurable | Treatment option | Neratinib | Capecitabine
Item
part 1: confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
boolean
C0280100 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0683525 (UMLS CUI [2])
C2713008 (UMLS CUI [3])
C0671970 (UMLS CUI [4])
Secondary malignant neoplasm of female breast | Locally advanced breast cancer
Item
part 2: confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
boolean
C0346993 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
HER2 gene amplification Neoplasm FISH | HER2 gene amplification Neoplasm CISH | ERBB2 Protein Overexpression Immunohistochemistry Positive
Item
part 2: erbb-2 gene amplified tumor (fish or cish) or erbb-2 overexpression (ihc 3+, or ihc2+ with fish or cish confirmation), based on local testing, or based on centralized fish testing prior to day 1.
boolean
C1512127 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C1512127 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C1516514 (UMLS CUI [2,3])
C1515560 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Disease Progression | trastuzumab | Therapeutic procedure Quantity Secondary malignant neoplasm of female breast | Therapeutic procedure Quantity Locally advanced breast cancer
Item
part 2: disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (prior adjuvant trastuzumab is allowed but not required). a 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0346993 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C3495949 (UMLS CUI [4,3])
Taxane | Neoadjuvant Therapy | Adjuvant therapy | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
boolean
C0215136 (UMLS CUI [1])
C0600558 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
C3495949 (UMLS CUI [4])
C0346993 (UMLS CUI [5])
Measurable lesion Quantity
Item
parts 1+2: at least 1 measurable lesion as defined by recist criteria.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography
Item
parts 1+2: lvef within institutional range of normal as measured by multi-gated acquisition (muga) or echocardiogram (echo).
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)
capecitabine | lapatinib | Pharmaceutical Preparations Targeting ERBB2 | Exception Trastuzumab
Item
part 2: prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbb-2 targeted agents except trastuzumab. treatment with erbb-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
boolean
C0671970 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0242957 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
Anthracyclines | Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracyclines Dose Equivalent
Item
part 2: prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines.
boolean
C0282564 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0282564 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
Disease Bone Site only
Item
parts 1+2: subjects with bone as the only site of disease.
boolean
C0012634 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
CNS metastases Uncontrolled | CNS metastases Symptomatic | Symptoms Clinical | Cerebral Edema | CNS metastases Growth Progressive | Definitive Treatment CNS metastases allowed | Definitive Treatment Compression of spinal cord allowed | Anticonvulsants Discontinued | Steroids Discontinued
Item
parts 1+2: active uncontrolled or symptomatic central nervous system (cns) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. subjects with a history of cns metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0006114 (UMLS CUI [4])
C0686377 (UMLS CUI [5,1])
C2911660 (UMLS CUI [5,2])
C0205329 (UMLS CUI [5,3])
C2986592 (UMLS CUI [6,1])
C0686377 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C2986592 (UMLS CUI [7,1])
C0037926 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
C0003286 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0038317 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
parts 1+2: any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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