ID

37943

Beskrivning

Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01304797

Länk

https://clinicaltrials.gov/show/NCT01304797

Nyckelord

Versioner (1)
  1. 2019-09-02 2019-09-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01304797

Engelsk

Eligibility Breast Cancer NCT01304797

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced/unresectable or metastatic breast cancer
Beskrivning

Locally advanced breast cancer unresectable | Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0346993
eighteen years of age or above
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and sign an informed consent (or have a legal representative who is able to do so)
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
measurable disease according to recist v1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance score of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, hepatic, renal and cardiac function
Beskrivning

Bone Marrow function | Liver function | Renal function | Cardiac function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232164
willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-302
Beskrivning

Sexual Abstinence | Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0036899
UMLS CUI [2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients for whom potentially curative anticancer therapy is available
Beskrivning

Availability of Cancer treatment Curative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1276305
active infection or fever > 38.5°c during screening visits or on the first scheduled day of dosing
Beskrivning

Communicable Disease | Fever

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0015967
symptomatic cns disease
Beskrivning

CNS disorder Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0231220
known hypersensitivity to any of the components of mm-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
Beskrivning

Hypersensitivity Component MM-302 | Allergic Reaction Monoclonal Antibodies Human

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C3272509
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0003250
UMLS CUI [2,3]
C0086418
received other recent antitumor therapy
Beskrivning

Cancer treatment Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
pregnant or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with any other medical or psychological condition, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Beskrivning

Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Informed Consent | Mental condition Interferes with Compliance behavior | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0021430
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1321605
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0459471
UMLS CUI [8,4]
C0683954
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Similar models

Eligibility Breast Cancer NCT01304797

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer unresectable | Secondary malignant neoplasm of female breast
Item
locally advanced/unresectable or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Age
Item
eighteen years of age or above
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
able to understand and sign an informed consent (or have a legal representative who is able to do so)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease according to recist v1.1
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Cardiac function
Item
adequate bone marrow, hepatic, renal and cardiac function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
Sexual Abstinence | Contraceptive methods
Item
willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-302
boolean
C0036899 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Availability of Cancer treatment Curative
Item
patients for whom potentially curative anticancer therapy is available
boolean
C0470187 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Communicable Disease | Fever
Item
active infection or fever > 38.5°c during screening visits or on the first scheduled day of dosing
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
CNS disorder Symptomatic
Item
symptomatic cns disease
boolean
C0007682 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hypersensitivity Component MM-302 | Allergic Reaction Monoclonal Antibodies Human
Item
known hypersensitivity to any of the components of mm-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C3272509 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
C0086418 (UMLS CUI [2,3])
Cancer treatment Other
Item
received other recent antitumor therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Informed Consent | Mental condition Interferes with Compliance behavior | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Interpretation Research results
Item
patients with any other medical or psychological condition, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
C3840291 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
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