ID

30588

Descrizione

Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00645333

collegamento

https://clinicaltrials.gov/show/NCT00645333

Keywords

versioni (1)
  1. 17/06/18 17/06/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

17 giugno 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00645333

Inglese

Eligibility Metastatic Breast Cancer NCT00645333

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women with metastatic (stage iv) breast cancer, or with locally advanced breast cancer (stages iiia > 10 cm, or stages iiib and iiic) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy
Descrizione

Gender | Secondary malignant neoplasm of female breast | Locally advanced breast cancer TNM clinical staging | First line Chemotherapy Unresponsive to Treatment | Anthracyclines | Docetaxel Recommended

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C3495949
UMLS CUI [3,2]
C3258246
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0205269
UMLS CUI [5]
C0282564
UMLS CUI [6,1]
C0246415
UMLS CUI [6,2]
C0034866
presence of measurable or evaluable disease
Descrizione

Measurable Disease | Evaluable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
adequate organ function
Descrizione

Organ function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0678852
ability to swallow intact study drug capsules
Descrizione

Able to swallow Investigational New Drug capsules

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0006935
zubrod performance status of 0-1 with at least a 3 month life expectancy
Descrizione

Zubrod Performance Status | Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C0023671
appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity
Descrizione

Elapsed Time Since Antineoplastic Therapy | Toxicity Resolution

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C2346834
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1514893
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent treatment with hormonal therapy intended to treat cancer
Descrizione

Hormone Therapy Malignant Neoplasms

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0006826
radiotherapy within 7 days prior to first dose
Descrizione

Therapeutic radiology procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1522449
symptomatic central nervous system, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks
Descrizione

CNS metastases Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Meningeal Carcinomatosis Symptomatic | Therapeutic radiology procedure Completed

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0014537
UMLS CUI [2,2]
C0027627
UMLS CUI [2,3]
C0231220
UMLS CUI [3,1]
C0220654
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205197
serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment
Descrizione

Comorbidity Serious | Cancer treatment Limited

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0439801
patients who are pregnant or nursing
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)
Descrizione

Factor Interferes with Interpretation Research data | Cancer Other

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0681873
UMLS CUI [2]
C1707251
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Similar models

Eligibility Metastatic Breast Cancer NCT00645333

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Secondary malignant neoplasm of female breast | Locally advanced breast cancer TNM clinical staging | First line Chemotherapy Unresponsive to Treatment | Anthracyclines | Docetaxel Recommended
Item
men or women with metastatic (stage iv) breast cancer, or with locally advanced breast cancer (stages iiia > 10 cm, or stages iiib and iiic) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy
boolean
C0079399 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C3495949 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1708063 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0205269 (UMLS CUI [4,3])
C0282564 (UMLS CUI [5])
C0246415 (UMLS CUI [6,1])
C0034866 (UMLS CUI [6,2])
Measurable Disease | Evaluable Disease
Item
presence of measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Able to swallow Investigational New Drug capsules
Item
ability to swallow intact study drug capsules
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
Zubrod Performance Status | Life Expectancy
Item
zubrod performance status of 0-1 with at least a 3 month life expectancy
boolean
C3714786 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Elapsed Time Since Antineoplastic Therapy | Toxicity Resolution
Item
appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity
boolean
C2826303 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C2346834 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Malignant Neoplasms
Item
concurrent treatment with hormonal therapy intended to treat cancer
boolean
C0279025 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Therapeutic radiology procedure
Item
radiotherapy within 7 days prior to first dose
boolean
C1522449 (UMLS CUI [1])
CNS metastases Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Meningeal Carcinomatosis Symptomatic | Therapeutic radiology procedure Completed
Item
symptomatic central nervous system, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0014537 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0220654 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Comorbidity Serious | Cancer treatment Limited
Item
serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Factor Interferes with Interpretation Research data | Cancer Other
Item
confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)
boolean
C1521761 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
C1707251 (UMLS CUI [2])
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