ID

16912

Beskrivning

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00425672

Länk

https://clinicaltrials.gov/show/NCT00425672

Nyckelord

Versioner (1)
  1. 2016-08-13 2016-08-13 -
Uppladdad den

13 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Male Breast Cancer NCT00425672

Engelsk

Eligibility Male Breast Cancer NCT00425672

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced stage refractory breast cancer
Beskrivning

Refractory breast cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205269
progressive or relapsed disease following standard therapy
Beskrivning

progressive or relapsed disease following standard therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0087111
patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional ct techniques or >= 10 mm with spiral ct scan; measurable (bi-dimensional) chest wall disease will also be allowed
Beskrivning

Measurable disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
Beskrivning

Cytotoxic chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0677881
white blood cell count (wbc) > 3.0 thou/ul
Beskrivning

White blood cell count

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
anc > 1.0 thou/ul
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelets >= 100 thou/ul
Beskrivning

Platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine =< 2.0 mg/dl or creatinine clearance (calculated) >= 60 ml/min
Beskrivning

Serum creatinine or creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
alt/ast =< 2.0 x upper limit of normal
Beskrivning

ALT/AST

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin =< 1.5 x upper limit of normal
Beskrivning

Total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
albumin >= 3.0 g/dl
Beskrivning

Albumin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201838
subjects must have a performance status score (ecog scale) =< 2
Beskrivning

ECOG

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
Beskrivning

Active concurrent medical illness precluding protocol treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ontak treatment is discontinued
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with ontak (dab389 il-2) or dab486 il-2
Beskrivning

Prior treatment with ontak (dab389 il-2) or dab486 il-2

Datatyp

boolean

Alias
UMLS CUI [1]
C0722264
UMLS CUI [2]
C0063713
known history of hypersensitivity to diphtheria toxin or il-2
Beskrivning

Hypersensitivity to diphtheria toxin or il-2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012550
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021756
active autoimmune disease
Beskrivning

Autoimmune disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
known history of pulmonary disease except controlled asthma
Beskrivning

Pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
history of or pre-existing, cardiovascular disease as defined by new york heart association (nyha) class iii-iv categorization
Beskrivning

cardiovascular disease as defined by new york heart association class iii-iv categorization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C1275491
pregnant or breast-feeding women
Beskrivning

Pregnant or breast-feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Male Breast Cancer NCT00425672

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Refractory breast cancer
Item
patients with advanced stage refractory breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
progressive or relapsed disease following standard therapy
Item
progressive or relapsed disease following standard therapy
boolean
C0677932 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Measurable disease
Item
patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional ct techniques or >= 10 mm with spiral ct scan; measurable (bi-dimensional) chest wall disease will also be allowed
boolean
C1513041 (UMLS CUI [1])
Cytotoxic chemotherapy
Item
patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
boolean
C0677881 (UMLS CUI [1])
White blood cell count
Item
white blood cell count (wbc) > 3.0 thou/ul
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
anc > 1.0 thou/ul
boolean
C0200633 (UMLS CUI [1])
Platelet count
Item
platelets >= 100 thou/ul
boolean
C0032181 (UMLS CUI [1])
Serum creatinine or creatinine clearance
Item
serum creatinine =< 2.0 mg/dl or creatinine clearance (calculated) >= 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
ALT/AST
Item
alt/ast =< 2.0 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Total bilirubin
Item
total bilirubin =< 1.5 x upper limit of normal
boolean
C0201913 (UMLS CUI [1])
Albumin
Item
albumin >= 3.0 g/dl
boolean
C0201838 (UMLS CUI [1])
ECOG
Item
subjects must have a performance status score (ecog scale) =< 2
boolean
C1520224 (UMLS CUI [1])
Active concurrent medical illness precluding protocol treatment
Item
subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
boolean
C0525058 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Contraceptive methods
Item
men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ontak treatment is discontinued
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior treatment with ontak (dab389 il-2) or dab486 il-2
Item
prior treatment with ontak (dab389 il-2) or dab486 il-2
boolean
C0722264 (UMLS CUI [1])
C0063713 (UMLS CUI [2])
Hypersensitivity to diphtheria toxin or il-2
Item
known history of hypersensitivity to diphtheria toxin or il-2
boolean
C0020517 (UMLS CUI [1,1])
C0012550 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021756 (UMLS CUI [2,2])
Autoimmune disease
Item
active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Pulmonary disease
Item
known history of pulmonary disease except controlled asthma
boolean
C0024115 (UMLS CUI [1])
cardiovascular disease as defined by new york heart association class iii-iv categorization
Item
history of or pre-existing, cardiovascular disease as defined by new york heart association (nyha) class iii-iv categorization
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnant or breast-feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tillbaka till toppen 

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