ID

18373

Description

Rollover Study Of Lapatinib In Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00169533

Link

https://clinicaltrials.gov/show/NCT00169533

Keywords

Versions (2)
  1. 10/31/16 10/31/16 -
  2. 11/2/16 11/2/16 -
Uploaded on

November 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasms, Breast NCT00169533

English

Eligibility Neoplasms, Breast NCT00169533

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently receiving clinical benefit as defined by cr, pr or sd from treatment with lapatinib through participation in a phase i study of lapatinib either as monotherapy or as part of a combination regimen.
Description

Study Subject Participation Status | lapatinib | Therapeutic procedure | Combined Modality Therapy | Tumor status In complete remission | Tumor status partial response | Tumor status Stable Disease

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1506770
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0009429
UMLS CUI [5,1]
C0475752
UMLS CUI [5,2]
C0677874
UMLS CUI [6,1]
C0475752
UMLS CUI [6,2]
C1521726
UMLS CUI [7,1]
C0475752
UMLS CUI [7,2]
C0677946
ability to understand and provide written informed consent to participate in this trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
is male or female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
female and male subjects agree to the protocol specific birth control measures
Description

Gender | Contraceptive methods agreement

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0680240
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
Description

lapatinib Discontinued Permanent | intolerance to lapatinib | lapatinib treatment failure

Data type

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0205355
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1506770
UMLS CUI [3,1]
C1506770
UMLS CUI [3,2]
C0162643
is a pregnant or lactating female.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
Description

Medically unfit Related Clinical Trial | patient interview | Physical Examination | Screening procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0220908
currently receiving treatment with any medications listed on the prohibited medication list (see section 7.2).
Description

Illicit drug use

Data type

boolean

Alias
UMLS CUI [1]
C0281875
has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.
Description

Heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
has a left ventricular ejection fraction (lvef) < 40% based on muga or echo.
Description

Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
UMLS CUI [3]
C0013516
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Similar models

Eligibility Neoplasms, Breast NCT00169533

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | lapatinib | Therapeutic procedure | Combined Modality Therapy | Tumor status In complete remission | Tumor status partial response | Tumor status Stable Disease
Item
currently receiving clinical benefit as defined by cr, pr or sd from treatment with lapatinib through participation in a phase i study of lapatinib either as monotherapy or as part of a combination regimen.
boolean
C2348568 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
C0475752 (UMLS CUI [5,1])
C0677874 (UMLS CUI [5,2])
C0475752 (UMLS CUI [6,1])
C1521726 (UMLS CUI [6,2])
C0475752 (UMLS CUI [7,1])
C0677946 (UMLS CUI [7,2])
Informed Consent
Item
ability to understand and provide written informed consent to participate in this trial.
boolean
C0021430 (UMLS CUI [1])
Gender
Item
is male or female.
boolean
C0079399 (UMLS CUI [1])
Gender | Contraceptive methods agreement
Item
female and male subjects agree to the protocol specific birth control measures
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
lapatinib Discontinued Permanent | intolerance to lapatinib | lapatinib treatment failure
Item
permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
boolean
C1506770 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C1506770 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
is a pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medically unfit Related Clinical Trial | patient interview | Physical Examination | Screening procedure
Item
is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
boolean
C3841806 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
Illicit drug use
Item
currently receiving treatment with any medications listed on the prohibited medication list (see section 7.2).
boolean
C0281875 (UMLS CUI [1])
Heart failure | New York Heart Association Classification
Item
has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
has a left ventricular ejection fraction (lvef) < 40% based on muga or echo.
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
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