ID

26303

Description

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00706030

Link

https://clinicaltrials.gov/show/NCT00706030

Keywords

Versions (1)
  1. 10/16/17 10/16/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00706030

English

Eligibility Breast Cancer NCT00706030

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which hki-272 plus vinorelbine is a reasonable treatment option (part 1 only) or confirmed pathologic diagnosis of erbb-2-positive breast cancer (current stage iv) in female subjects for which vinorelbine plus hki-272 is a reasonable treatment option (part 2 only).
Description

Solid tumour incurable | HKI 272 Treatment option | Vinorelbine Treatment option | Breast Carcinoma HER2/Neu Positive TNM Breast tumor staging | Gender

Data type

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0175969
UMLS CUI [2,1]
C1454298
UMLS CUI [2,2]
C0683525
UMLS CUI [3,1]
C0078257
UMLS CUI [3,2]
C0683525
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C2348909
UMLS CUI [4,3]
C0474926
UMLS CUI [5]
C0079399
at least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
Description

Chemotherapy Regimen Quantity Neoplasm Metastasis | trastuzumab | Adjuvant therapy | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0677850
UMLS CUI [4]
C0277556
at least 1 measurable lesion as defined by response evaluation criteria in solid tumors (recist).
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).
Description

Antineoplastic Therapy Quantity Neoplasm Metastasis | Exception Hormone Therapy | Adjuvant therapy | Recurrent disease | Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
UMLS CUI [3]
C0677850
UMLS CUI [4]
C0277556
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0027627
prior treatment with vinorelbine for metastatic setting, or prior treatment with any erbb-2 targeted agents except trastuzumab (part 2 only). up to 20 subjects with erbb-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
Description

Vinorelbine Neoplasm Metastasis | Pharmaceutical Preparations Targeting erbB-2 | Exception trastuzumab | Secondary malignant neoplasm of female breast erbB-2 Overexpression | lapatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0078257
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0069515
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0728747
UMLS CUI [4,1]
C0346993
UMLS CUI [4,2]
C0069515
UMLS CUI [4,3]
C1514559
UMLS CUI [5]
C1506770
prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).
Description

Anthracyclines | Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracycline Derivatives Dose Equivalent

Data type

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]
C0243072
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0205163
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Similar models

Eligibility Breast Cancer NCT00706030

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Solid tumour incurable | HKI 272 Treatment option | Vinorelbine Treatment option | Breast Carcinoma HER2/Neu Positive TNM Breast tumor staging | Gender
Item
confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which hki-272 plus vinorelbine is a reasonable treatment option (part 1 only) or confirmed pathologic diagnosis of erbb-2-positive breast cancer (current stage iv) in female subjects for which vinorelbine plus hki-272 is a reasonable treatment option (part 2 only).
boolean
C0280100 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C1454298 (UMLS CUI [2,1])
C0683525 (UMLS CUI [2,2])
C0078257 (UMLS CUI [3,1])
C0683525 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C0474926 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5])
Chemotherapy Regimen Quantity Neoplasm Metastasis | trastuzumab | Adjuvant therapy | Recurrent disease
Item
at least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Measurable lesion Quantity
Item
at least 1 measurable lesion as defined by response evaluation criteria in solid tumors (recist).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Antineoplastic Therapy Quantity Neoplasm Metastasis | Exception Hormone Therapy | Adjuvant therapy | Recurrent disease | Chemotherapy Neoplasm Metastasis
Item
more than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).
boolean
C2346834 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
Vinorelbine Neoplasm Metastasis | Pharmaceutical Preparations Targeting erbB-2 | Exception trastuzumab | Secondary malignant neoplasm of female breast erbB-2 Overexpression | lapatinib
Item
prior treatment with vinorelbine for metastatic setting, or prior treatment with any erbb-2 targeted agents except trastuzumab (part 2 only). up to 20 subjects with erbb-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
boolean
C0078257 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0069515 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
C0346993 (UMLS CUI [4,1])
C0069515 (UMLS CUI [4,2])
C1514559 (UMLS CUI [4,3])
C1506770 (UMLS CUI [5])
Anthracyclines | Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracycline Derivatives Dose Equivalent
Item
prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).
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])
C0243072 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205163 (UMLS CUI [4,4])
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