ID

30575

Beschrijving

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

Trefwoorden

Versies (2)
  1. 16-06-18 16-06-18 -
  2. 16-06-18 16-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 juni 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Metastatic Breast Cancer NCT00454532

Engels

Eligibility Metastatic Breast Cancer NCT00454532

1 Formulieren  
Criteria
Beschrijving

Criteria

women 18 years or older
Beschrijving

Gender | Age

Datatype

boolean

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

Breast Carcinoma

Datatype

boolean

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

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

Datatype

boolean

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

Availability of Estrogen Receptor Status | Availability of Progesterone Receptor Status

Datatype

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
Beschrijving

Measurable Disease Site Quantity

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Life Expectancy

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Childbearing Potential Contraceptive methods Quantity

Datatype

boolean

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

Exclusion Criteria Main

Datatype

boolean

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

Informed Consent Unable | Informed Consent Unwilling

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Investigational New Drugs

Datatype

boolean

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

Abnormality of the gastrointestinal tract

Datatype

boolean

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

Coumadin Dose Therapeutic | Investigational New Drugs

Datatype

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
Beschrijving

Palliative Radiation Therapy | Cancer treatment

Datatype

boolean

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

Pregnancy | Breast Feeding | Pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0240802
Terug naar het begin van de pagina

Similar models

Eligibility Metastatic Breast Cancer NCT00454532

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial