ID

37858

Beskrivning

Safety Study of MGAH22 in HER2-positive Carcinomas; ODM derived from: https://clinicaltrials.gov/show/NCT01148849

Länk

https://clinicaltrials.gov/show/NCT01148849

Nyckelord

Versioner (1)
  1. 2019-08-28 2019-08-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01148849

Engelsk

Eligibility Breast Cancer NCT01148849

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed carcinoma that overexpresses her2 by immunohistochemistry (2+ or 3+ positivity by herceptest or equivalent).
Beskrivning

Carcinoma HER2 Protein Overexpression Immunohistochemistry | HercepTest Positive | Equivalent Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C1515560
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C1512416
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0205163
UMLS CUI [3,2]
C1514241
progressive disease during or after last treatment regimen.
Beskrivning

Progressive Disease During Therapeutic procedure | Progressive Disease Post Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
appropriate treatment history for histological entity.
Beskrivning

History Treatment Appropriate Histology

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1548787
UMLS CUI [1,4]
C4048239
ecog performance status <= 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy >= 3 month.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
measurable disease
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
acceptable laboratory parameters and adequate organ reserve.
Beskrivning

Laboratory parameters | Organ function Total

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0449381
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C0439810
baseline lvef >50%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
lifetime anthracycline exposure > 350 mg/m2 of doxorubicin or equivalent
Beskrivning

Exposure to Anthracyclines Lifetime | Doxorubicin | Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C4071830
UMLS CUI [2]
C0013089
UMLS CUI [3]
C0205163
major surgery within four weeks before enrollment.
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.
Beskrivning

Hypersensitivity Murine protein | Hypersensitivity Recombinant Proteins | Hypersensitivity Polysorbate 80 | Hypersensitivity Drug Formulation Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0034861
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0032601
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0524527
UMLS CUI [4,3]
C0015237
second primary malignancy that has not been in remission for greater than 3 years. treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on pap smear, localized prostate cancer (gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.
Beskrivning

Neoplasms, Second Primary | Absence Remission Duration | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Biopsy | Exception Squamous intraepithelial lesion Pap smear | Exception Prostate carcinoma Localized Gleason score | Exception Melanoma in situ Resected

Datatyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0687702
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C0005558
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0333873
UMLS CUI [5,3]
C0079104
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C0392752
UMLS CUI [6,4]
C3203027
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0854696
UMLS CUI [7,3]
C1521996
active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
Beskrivning

Virus Disease | Bacterial Infection | Systemic mycosis | Requirement Parenteral therapy | Patient need for Antiviral Therapy Oral | Patient need for Antifungal therapy Oral | Patient need for Anti-Bacterial Agents Oral | Treatment completed Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0042769
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0553576
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0259961
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0280274
UMLS CUI [5,3]
C1527415
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C0678026
UMLS CUI [6,3]
C1527415
UMLS CUI [7,1]
C0686904
UMLS CUI [7,2]
C0279516
UMLS CUI [7,3]
C1527415
UMLS CUI [8,1]
C0580352
UMLS CUI [8,2]
C1514873
history of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
Beskrivning

Chronic infectious disease | Recurrent infections | Requirement Antiviral Agents | Requirement Antifungal Agents | Requirement Anti-Bacterial Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0239998
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003451
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003308
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0279516
history of deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke within three months of enrollment.
Beskrivning

Deep Vein Thrombosis | Pulmonary Embolism | Myocardial Infarction | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
known history of central nervous system (cns) metastatic disease with evidence of residual or recurrent disease upon entry.
Beskrivning

CNS metastases | Residual disease | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0543478
UMLS CUI [3]
C0277556
new york heart association class iii or iv heart disease.
Beskrivning

Heart Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Breast Cancer NCT01148849

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma HER2 Protein Overexpression Immunohistochemistry | HercepTest Positive | Equivalent Positive
Item
histologically or cytologically confirmed carcinoma that overexpresses her2 by immunohistochemistry (2+ or 3+ positivity by herceptest or equivalent).
boolean
C0007097 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C1512416 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Progressive Disease During Therapeutic procedure | Progressive Disease Post Therapeutic procedure
Item
progressive disease during or after last treatment regimen.
boolean
C1335499 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1335499 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
History Treatment Appropriate Histology
Item
appropriate treatment history for histological entity.
boolean
C0262926 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1548787 (UMLS CUI [1,3])
C4048239 (UMLS CUI [1,4])
ECOG performance status
Item
ecog performance status <= 1.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >= 3 month.
boolean
C0023671 (UMLS CUI [1])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Laboratory parameters | Organ function Total
Item
acceptable laboratory parameters and adequate organ reserve.
boolean
C0022877 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
baseline lvef >50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exposure to Anthracyclines Lifetime | Doxorubicin | Equivalent
Item
lifetime anthracycline exposure > 350 mg/m2 of doxorubicin or equivalent
boolean
C0332157 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C4071830 (UMLS CUI [1,3])
C0013089 (UMLS CUI [2])
C0205163 (UMLS CUI [3])
Major surgery
Item
major surgery within four weeks before enrollment.
boolean
C0679637 (UMLS CUI [1])
Hypersensitivity Murine protein | Hypersensitivity Recombinant Proteins | Hypersensitivity Polysorbate 80 | Hypersensitivity Drug Formulation Excipient
Item
known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0034861 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0032601 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Neoplasms, Second Primary | Absence Remission Duration | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Biopsy | Exception Squamous intraepithelial lesion Pap smear | Exception Prostate carcinoma Localized Gleason score | Exception Melanoma in situ Resected
Item
second primary malignancy that has not been in remission for greater than 3 years. treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on pap smear, localized prostate cancer (gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.
boolean
C0085183 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0687702 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0333873 (UMLS CUI [5,2])
C0079104 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C0392752 (UMLS CUI [6,3])
C3203027 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0854696 (UMLS CUI [7,2])
C1521996 (UMLS CUI [7,3])
Virus Disease | Bacterial Infection | Systemic mycosis | Requirement Parenteral therapy | Patient need for Antiviral Therapy Oral | Patient need for Antifungal therapy Oral | Patient need for Anti-Bacterial Agents Oral | Treatment completed Required
Item
active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
boolean
C0042769 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0259961 (UMLS CUI [4,2])
C0686904 (UMLS CUI [5,1])
C0280274 (UMLS CUI [5,2])
C1527415 (UMLS CUI [5,3])
C0686904 (UMLS CUI [6,1])
C0678026 (UMLS CUI [6,2])
C1527415 (UMLS CUI [6,3])
C0686904 (UMLS CUI [7,1])
C0279516 (UMLS CUI [7,2])
C1527415 (UMLS CUI [7,3])
C0580352 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
Chronic infectious disease | Recurrent infections | Requirement Antiviral Agents | Requirement Antifungal Agents | Requirement Anti-Bacterial Agents
Item
history of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
boolean
C0151317 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0003451 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0003308 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0279516 (UMLS CUI [5,2])
Deep Vein Thrombosis | Pulmonary Embolism | Myocardial Infarction | Cerebrovascular accident
Item
history of deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke within three months of enrollment.
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
CNS metastases | Residual disease | Recurrent disease
Item
known history of central nervous system (cns) metastatic disease with evidence of residual or recurrent disease upon entry.
boolean
C0686377 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Heart Disease New York Heart Association Classification
Item
new york heart association class iii or iv heart disease.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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