ID

37943

Description

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

Link

https://clinicaltrials.gov/show/NCT01304797

Keywords

Versions (1)
  1. 9/2/19 9/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01304797

English

Eligibility Breast Cancer NCT01304797

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

boolean

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

Age

Data type

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)
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

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

Measurable Disease

Data type

boolean

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

ECOG performance status

Data type

boolean

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

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

Data type

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
Description

Sexual Abstinence | Contraceptive methods

Data type

boolean

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

Exclusion Criteria

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

Availability of Cancer treatment Curative

Data type

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
Description

Communicable Disease | Fever

Data type

boolean

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

CNS disorder Symptomatic

Data type

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
Description

Hypersensitivity Component MM-302 | Allergic Reaction Monoclonal Antibodies Human

Data type

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
Description

Cancer treatment Other

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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