ID

26303

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00706030

Keywords

versioni (1)
  1. 16/10/17 16/10/17 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

16 ottobre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Breast Cancer NCT00706030

Inglese

Eligibility Breast Cancer NCT00706030

1 moduli  
Inclusion Criteria
Descrizione

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).
Descrizione

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

Tipo di dati

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).
Descrizione

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

Tipo di dati

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).
Descrizione

Measurable lesion Quantity

Tipo di dati

boolean

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

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).
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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).
Descrizione

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

Tipo di dati

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
Ritorna all'inizio della pagina

Similar models

Eligibility Breast Cancer NCT00706030

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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