ID

31763

Beschreibung

A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT01521325

Link

https://clinicaltrials.gov/show/NCT01521325

Stichworte

Versionen (1)
  1. 26.09.18 26.09.18 -
Rechteinhaber

Morphotek

Hochgeladen am

26. September 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Mesothelioma NCT01521325

Englisch

Eligibility Mesothelioma NCT01521325

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male subjects > or = 18 years of age
Beschreibung

Gender, age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically confirmed mesothelin-expressing cancer
Beschreibung

Mesothelin-expressing cancer, histologically confirmed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C4288762
measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is > or = 1.5cm, as defined by recist v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry
Beschreibung

Prior measurable, progressed disease, non-hepatic lesion; symptoms supported by biomarker, radiological or pathological aspects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1709926
UMLS CUI [2]
C0475440
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0450429
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0023884
UMLS CUI [5,1]
C1516986
UMLS CUI [5,2]
C1457887
UMLS CUI [5,3]
C0005516
UMLS CUI [6,1]
C1516986
UMLS CUI [6,2]
C1457887
UMLS CUI [6,3]
C0043299
UMLS CUI [7,1]
C1516986
UMLS CUI [7,2]
C1457887
UMLS CUI [7,3]
C0205469
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy or hypersensitivity to monoclonal antibodies
Beschreibung

Allergy/ hypersensitivity to monoclonal antibodies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003250
known to develop haca
Beschreibung

Human Anti-Chimeric Antibody

Datentyp

boolean

Alias
UMLS CUI [1]
C4330329
prior treatment with amatuximab
Beschreibung

Prior therapy with amatuximab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2987611
prior treatment with ss1 (dsfv)pe38 (ss1p)
Beschreibung

Prior treatment with ss1 (dsfv)pe38 (ss1p)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4330608
UMLS CUI [1,3]
C0004630
UMLS CUI [1,4]
C0598658
prior treatment with another test article within previous 30 days
Beschreibung

prior therapy with experimental drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0304229
known brain metastasis
Beschreibung

Brain metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact
Beschreibung

Prosthesis which lead to artifact in diagnostic radiological examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175649
UMLS CUI [1,2]
C0043299
UMLS CUI [1,3]
C0085089
chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab
Beschreibung

Prior chemotherapy, biological therapy, radiation therapy or immunotherapy with amatuximab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2987611
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C1531518
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C2987611
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0332152
UMLS CUI [3,4]
C2987611
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0021083
UMLS CUI [4,3]
C0332152
UMLS CUI [4,4]
C2987611
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Ähnliche Modelle

Eligibility Mesothelioma NCT01521325

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender, age
Item
female and male subjects > or = 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Mesothelin-expressing cancer, histologically confirmed
Item
histologically confirmed mesothelin-expressing cancer
boolean
C0006826 (UMLS CUI [1,1])
C4288762 (UMLS CUI [1,2])
Prior measurable, progressed disease, non-hepatic lesion; symptoms supported by biomarker, radiological or pathological aspects
Item
measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is > or = 1.5cm, as defined by recist v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0450429 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0023884 (UMLS CUI [4,3])
C1516986 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0005516 (UMLS CUI [5,3])
C1516986 (UMLS CUI [6,1])
C1457887 (UMLS CUI [6,2])
C0043299 (UMLS CUI [6,3])
C1516986 (UMLS CUI [7,1])
C1457887 (UMLS CUI [7,2])
C0205469 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Allergy/ hypersensitivity to monoclonal antibodies
Item
known allergy or hypersensitivity to monoclonal antibodies
boolean
C0020517 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
Human Anti-Chimeric Antibody
Item
known to develop haca
boolean
C4330329 (UMLS CUI [1])
Prior therapy with amatuximab
Item
prior treatment with amatuximab
boolean
C1514463 (UMLS CUI [1,1])
C2987611 (UMLS CUI [1,2])
Prior treatment with ss1 (dsfv)pe38 (ss1p)
Item
prior treatment with ss1 (dsfv)pe38 (ss1p)
boolean
C1514463 (UMLS CUI [1,1])
C4330608 (UMLS CUI [1,2])
C0004630 (UMLS CUI [1,3])
C0598658 (UMLS CUI [1,4])
prior therapy with experimental drug
Item
prior treatment with another test article within previous 30 days
boolean
C1514463 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Brain metastasis
Item
known brain metastasis
boolean
C0220650 (UMLS CUI [1])
Prosthesis which lead to artifact in diagnostic radiological examination
Item
known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact
boolean
C0175649 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C0085089 (UMLS CUI [1,3])
Prior chemotherapy, biological therapy, radiation therapy or immunotherapy with amatuximab
Item
chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab
boolean
C0332185 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2987611 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C1531518 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2987611 (UMLS CUI [2,4])
C0332185 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C2987611 (UMLS CUI [3,4])
C0332185 (UMLS CUI [4,1])
C0021083 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
C2987611 (UMLS CUI [4,4])
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