ID

26562

Descripción

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

Palabras clave

Versiones (1)
  1. 19/10/17 19/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de octubre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00741260

Inglés

Eligibility Breast Cancer NCT00741260

1 formularios  
Inclusion Criteria
Descripción

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.
Descripción

Solid tumour incurable | Treatment option | Neratinib | Capecitabine

Tipo de datos

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.
Descripción

Secondary malignant neoplasm of female breast | Locally advanced breast cancer

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Measurable lesion Quantity

Tipo de datos

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).
Descripción

Left ventricular ejection fraction MUGA | 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
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.
Descripción

capecitabine | lapatinib | Pharmaceutical Preparations Targeting ERBB2 | Exception Trastuzumab

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Disease Bone Site only

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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
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Similar models

Eligibility Breast Cancer NCT00741260

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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