ID

30588

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00645333

Palavras-chave

Versões (1)
  1. 17/06/2018 17/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00645333

Inglês

Eligibility Metastatic Breast Cancer NCT00645333

1 Formulários  
Inclusion Criteria
Descrição

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
Descrição

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

Tipo de dados

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
Descrição

Measurable Disease | Evaluable Disease

Tipo de dados

boolean

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

Organ function

Tipo de dados

boolean

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

Able to swallow Investigational New Drug capsules

Tipo de dados

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
Descrição

Zubrod Performance Status | Life Expectancy

Tipo de dados

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
Descrição

Elapsed Time Since Antineoplastic Therapy | Toxicity Resolution

Tipo de dados

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
Descrição

Exclusion Criteria

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

Hormone Therapy Malignant Neoplasms

Tipo de dados

boolean

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

Therapeutic radiology procedure

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Comorbidity Serious | Cancer treatment Limited

Tipo de dados

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
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Factor Interferes with Interpretation Research data | Cancer Other

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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