ID

15592

Description

ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00046514

Link

https://clinicaltrials.gov/show/NCT00046514

Keywords

  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00046514

Eligibility Breast Neoplasms NCT00046514

Criteria
Description

Criteria

if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
Description

negative serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0430061
eighteen years of age or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky perfomance status of 70% or 0-2 swog performance status
Description

karnofsky perfomance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
Description

no other malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
measurable disease
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
suitable candidate for treatment with paclitaxel
Description

treatment with paclitaxel

Data type

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C0332149
previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
Description

previously treated with taxol

Data type

boolean

Alias
UMLS CUI [1]
C0144576
if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
Description

blood

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0005821
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
Description

blood measurements baseline

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201976
patient has an expected survival of at least 12 weeks
Description

expected survival

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient or his/her representative has signed an informed consent statement
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Breast Neoplasms NCT00046514

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
negative serum pregnancy test
Item
if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
boolean
C0430061 (UMLS CUI [1])
age
Item
eighteen years of age or older
boolean
C0001779 (UMLS CUI [1])
karnofsky perfomance status
Item
karnofsky perfomance status of 70% or 0-2 swog performance status
boolean
C0206065 (UMLS CUI [1])
no other malignancy
Item
no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
treatment with paclitaxel
Item
suitable candidate for treatment with paclitaxel
boolean
C0144576 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
previously treated with taxol
Item
previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
boolean
C0144576 (UMLS CUI [1])
blood
Item
if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
boolean
C0019046 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
blood measurements baseline
Item
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
expected survival
Item
patient has an expected survival of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
patient or his/her representative has signed an informed consent statement
boolean
C0021430 (UMLS CUI [1])

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