ID

30575

Beschreibung

A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00454532

Link

https://clinicaltrials.gov/show/NCT00454532

Stichworte

Versionen (2)
  1. 16.06.18 16.06.18 -
  2. 16.06.18 16.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00454532

Englisch

Eligibility Metastatic Breast Cancer NCT00454532

1 Formulare  
Criteria
Beschreibung

Criteria

women 18 years or older
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically confirmed breast cancer
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
clinical evidence of metastatic (stage iv) metastasis (other than bone metastasis)
Beschreibung

Secondary malignant neoplasm of female breast | Exception Secondary malignant neoplasm of bone

Datentyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0153690
availability of estrogen and progesterone receptor status
Beschreibung

Availability of Estrogen Receptor Status | Availability of Progesterone Receptor Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1516974
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1514471
at least one measurable disease site defined by recist criteria, 30 days prior to study therapy
Beschreibung

Measurable Disease Site Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
for the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. for the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
Beschreibung

Phase Number | Cytotoxic Chemotherapy Quantity Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0346993
life expectancy ≥ 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group performance status ≤2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
women of child bearing potential must agree to 2 forms of contraception during the course of the trial.
Beschreibung

Childbearing Potential Contraceptive methods Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
inability to understand/unwillingness to sign a written informed consent
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
Beschreibung

Adverse effects Chemotherapy Related | Adverse effects Therapeutic radiology procedure Related | Adverse effects Biological treatment Related | Adverse effects Hormone Therapy Related | Resolution failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C1531518
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0279025
UMLS CUI [4,3]
C0439849
UMLS CUI [5,1]
C1514893
UMLS CUI [5,2]
C0231175
currently using an investigational agent
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
clinically significant gastrointestinal abnormalities
Beschreibung

Abnormality of the gastrointestinal tract

Datentyp

boolean

Alias
UMLS CUI [1]
C4023588
currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
Beschreibung

Coumadin Dose Therapeutic | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0699129
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0302350
UMLS CUI [2]
C0013230
concurrent palliative radiation or anti-cancer treatment
Beschreibung

Palliative Radiation Therapy | Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C3898008
UMLS CUI [2]
C0920425
women who report pregnancy, are breast-feeding or have a positive pregnancy test
Beschreibung

Pregnancy | Breast Feeding | Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0240802
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Ähnliche Modelle

Eligibility Metastatic Breast Cancer NCT00454532

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Gender | Age
Item
women 18 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Secondary malignant neoplasm of female breast | Exception Secondary malignant neoplasm of bone
Item
clinical evidence of metastatic (stage iv) metastasis (other than bone metastasis)
boolean
C0346993 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
Availability of Estrogen Receptor Status | Availability of Progesterone Receptor Status
Item
availability of estrogen and progesterone receptor status
boolean
C0470187 (UMLS CUI [1,1])
C1516974 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1514471 (UMLS CUI [2,2])
Measurable Disease Site Quantity
Item
at least one measurable disease site defined by recist criteria, 30 days prior to study therapy
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Phase Number | Cytotoxic Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
for the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. for the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
boolean
C0205390 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0346993 (UMLS CUI [2,3])
Life Expectancy
Item
life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity
Item
women of child bearing potential must agree to 2 forms of contraception during the course of the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
inability to understand/unwillingness to sign a written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Adverse effects Chemotherapy Related | Adverse effects Therapeutic radiology procedure Related | Adverse effects Biological treatment Related | Adverse effects Hormone Therapy Related | Resolution failed
Item
any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
boolean
C0879626 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0879626 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0879626 (UMLS CUI [3,1])
C1531518 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0879626 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1514893 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
Investigational New Drugs
Item
currently using an investigational agent
boolean
C0013230 (UMLS CUI [1])
Abnormality of the gastrointestinal tract
Item
clinically significant gastrointestinal abnormalities
boolean
C4023588 (UMLS CUI [1])
Coumadin Dose Therapeutic | Investigational New Drugs
Item
currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
boolean
C0699129 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
Palliative Radiation Therapy | Cancer treatment
Item
concurrent palliative radiation or anti-cancer treatment
boolean
C3898008 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy test positive
Item
women who report pregnancy, are breast-feeding or have a positive pregnancy test
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0240802 (UMLS CUI [3])
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