ID

30588

Beschrijving

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

Trefwoorden

Versies (1)
  1. 17-06-18 17-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00645333

Engels

Eligibility Metastatic Breast Cancer NCT00645333

1 Formulieren  
Inclusion Criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

Measurable Disease | Evaluable Disease

Datatype

boolean

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

Organ function

Datatype

boolean

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

Able to swallow Investigational New Drug capsules

Datatype

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
Beschrijving

Zubrod Performance Status | Life Expectancy

Datatype

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
Beschrijving

Elapsed Time Since Antineoplastic Therapy | Toxicity Resolution

Datatype

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
Beschrijving

Exclusion Criteria

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

Hormone Therapy Malignant Neoplasms

Datatype

boolean

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

Therapeutic radiology procedure

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Comorbidity Serious | Cancer treatment Limited

Datatype

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
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Factor Interferes with Interpretation Research data | Cancer Other

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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