Study Subject Participation Status | Trial Phase | Lapatinib
Item
participation in a phase i lapatinib trial that has met its study objectives.
boolean
C2348568 (UMLS CUI [1])
C1710475 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
Informed Consent
Item
ability to understand and provide written informed consent to participate in this study.
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
a female subject is eligible to participate if she is of:
boolean
C0079399 (UMLS CUI [1])
Childbearing Potential Absent | Premenopausal state Tubal Ligation | Premenopausal state Hysterectomy | Postmenopausal state | Amenorrhea Spontaneous | Hormone replacement therapy Contraceptive methods | Menopausal Status Uncertain Contraceptive methods
Item
non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. females on hormone replacement therapy (hrt) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their hrt during the study. otherwise, they must discontinue hrt to allow confirmation of post-menopausal status prior to study enrollment. for most forms of hrt, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of hrt. following confirmation of their post-menopausal status, they can resume use of hrt during the study without use of a contraceptive method.
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0520483 (UMLS CUI [2,2])
C0232969 (UMLS CUI [3,1])
C0020699 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0002453 (UMLS CUI [5,1])
C0205359 (UMLS CUI [5,2])
C0282402 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C3829127 (UMLS CUI [7,1])
C0087130 (UMLS CUI [7,2])
C0700589 (UMLS CUI [7,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. female subjects must agree to use contraception from two weeks prior to the administration of study drug and throughout the entire active study treatment period until four weeks after the last dose of study medication.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Lapatinib Discontinuation Permanent | Etiology Intolerance to Lapatinib | Etiology 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])
C0015127 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
C1506770 (UMLS CUI [2,3])
C0015127 (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])
Study Subject Participation Status Medically unfit | Patient interview | Physical Examination | Baseline Investigation
Item
is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or baseline investigations.
boolean
C2348568 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C1442488 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
Pharmaceutical Preparations Illicit
Item
currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
boolean
C0013227 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
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 [1,1])
C1275491 (UMLS CUI [1,2])
Liver disease | Gall Bladder Disease | Exception Gilbert Disease | Exception Kidney Calculi Asymptomatic | Exception Secondary malignant neoplasm of liver | Exception Chronic liver disease Stable
Item
have current active hepatic or biliary disease (with exception of subjects with gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
boolean
C0023895 (UMLS CUI [1])
C0016977 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0022650 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0341439 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])