HER2-positive carcinoma of breast confirmed by IHC, FISH or CISH, metastatic Solid Neoplasm which is unresponsive to treatment or no approved therapy but lapatinib with eligible cancer treatment
Item
Histologically or cytologically confirmed diagnosis of metastatic breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive) or recurrent, advanced, or metastatic solid tumor malignancy that is either refractory to standard therapies or for which there is no approved therapy and for which lapatinib in combination with one of the permitted anti-cancer regimens in the continuation protocol EGF111767 may be suitable.
boolean
C1960398 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C1960398 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1960398 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0299250 (UMLS CUI [3,3])
C0280100 (UMLS CUI [4,1])
C0006142 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0205269 (UMLS CUI [4,4])
C0280100 (UMLS CUI [5,1])
C0006142 (UMLS CUI [5,2])
C0027627 (UMLS CUI [5,3])
C0087111 (UMLS CUI [5,4])
C0205540 (UMLS CUI [5,5])
C0332197 (UMLS CUI [5,6])
C0087111 (UMLS CUI [6,1])
C0006142 (UMLS CUI [6,2])
C0027627 (UMLS CUI [6,3])
C1506770 (UMLS CUI [6,4])
C0920425 (UMLS CUI [6,5])
C1548635 (UMLS CUI [6,6])
Gender, Age
Item
Male and female, at least 18 years of age and not greater than 75 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-childbearing potential, willing to use contraceptive precautions, negative pregnancy test
Item
A female is eligible to enter and participate in the study if she is of: 1. Non-childbearing potential (i.e. physiologically incapable of becoming pregnant), including any female who has had a hysterectomy; has had a bilateral oophorectomy (ovariectomy); has had a bilateral tubal ligation, or is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year) or in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory. 2. Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the contraceptive precautions.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
C0427780 (UMLS CUI [3])
Ability to swallow and retain oral medication
Item
Is able to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
ECOG performance status
Item
ECOG performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
bone marrow, physiological aspects, hemoglobin measurement, Granulocyte count, blood platelets
Item
Adequate bone marrow function. Hemoglobin ≥ 9 gm/dL, absolute granulocyte count ≥ 1,500/mm3 (1.5 x 109/L), Platelets ≥ 75,000/mm3 (75 x 109/L).
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0857490 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
Estimation of creatinine clearance based on Cockcroft-Gault formula, INR, bilirubin total measurement, AST
Item
Calculated creatinine clearance (CrCl) ≥ 50 ml/min based on Cockcroft and Gault, total bilirubin ≤ 1.5 X upper limit of normal of institutional values and INR ≤ 1.5, Alanine transaminase (ALT) ≤ three times the upper limit of the institutional values or ≤ five times ULN with documented liver metastases.
boolean
C2711451 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
LVEF measurement base on ECHO or MUGA
Item
Has a left ventricular ejection fraction (LVEF) within the normal institutional range based on ECHO or MUGA.
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Life expectancy
Item
Life expectancy of ≥12 weeks
boolean
C0023671 (UMLS CUI [1])
Capability of giving informed consent, Protocol Compliance
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Pregnancy, breast feeding
Item
Is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
malabsorption syndrome, disease affecting gastrointestinal function, resection of colon, stomach or small bowel
Item
Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the colon, stomach or small bowel.
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C4069040 (UMLS CUI [3])
C0038351 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C0192601 (UMLS CUI [5])
active hepatic disease, current biliary disease, except for Gilbert's syndrome, asymptomatic gallstones, liver metastases or patient with assessed stable chronic liver disease
Item
Has current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
boolean
C2707252 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C2707252 (UMLS CUI [2,1])
C0016977 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0008350 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C0332300 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
C0332300 (UMLS CUI [6,1])
C0341439 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0022423 (UMLS CUI [6,4])
C0008961 (UMLS CUI [6,5])
symptomatic or uncontrolled brain metastases, leptomeningeal disease
Item
Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0231220 (UMLS CUI [3,1])
C0751297 (UMLS CUI [3,2])
C0205318 (UMLS CUI [4,1])
C0751297 (UMLS CUI [4,2])
medically unfit as a result of medical interview, physical exam or screening investigation
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])
C0683518 (UMLS CUI [1,2])
C3841806 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3841806 (UMLS CUI [3,1])
C0281974 (UMLS CUI [3,2])
hypersensitivity or idiosyncrasy to procedure-related pharmaceutical preparations such as gefitinib, erlotinib
Item
Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product such as gefitinib [Iressa] and erlotinib [Tarceva].
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2924519 (UMLS CUI [1,3])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2924519 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1122962 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1135135 (UMLS CUI [4,2])
C0231191 (UMLS CUI [5,1])
C1122962 (UMLS CUI [5,2])
C0231191 (UMLS CUI [6,1])
C1135135 (UMLS CUI [6,2])
treatment with experimental drug, recent
Item
Has received treatment with any investigational drug in the previous four weeks.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
recent chemotherapy, immunotherapy, biological therapy, hormonal therapy for cancer treatment and mitomycin
Item
Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy for the treatment of cancer within the past 14 days, with the exception of mitomycin C which is restricted for the past six weeks.
boolean
C0392920 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0021083 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0005527 (UMLS CUI [4,1])
C0920425 (UMLS CUI [4,2])
C0332185 (UMLS CUI [4,3])
C0002475 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
taking prohibited medication within the timeframe
Item
Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list
boolean
C0013227 (UMLS CUI [1,1])
C0683610 (UMLS CUI [1,2])
C1290952 (UMLS CUI [1,3])
physiological, familial, sociological or geographical conditions, protocol compliance
Item
Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
boolean
C0205463 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
inadequate venous access
Item
Has inadequate venous access for protocol-related blood draws.
boolean
C0750164 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
ECG abnormality, baseline QTc prolongation
Item
Clinically significant electrocardiogram(ECG) abnormality including baseline QTc prolongation >480msec.
boolean
C1969409 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
heparin hypersensitivity, heparin-induces thrombocytopenia
Item
History of sensitivity to heparin or heparin-induced thrombocytopenia.
boolean
C0019134 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
recent consumption of red wine, seville oranges, grapefruits, grapefruit juice, kumquats, pummelos, exotic citrus fruits or grapefruit hybrids
Item
Has consumed red wine, seville oranges, grapefruit or grapefruit juice and/or kumquats, pummelos, exotic citrus fruit (i.e. star fruit, bitter melon), grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
boolean
C0995150 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0452456 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0349371 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0330922 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0453281 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C1006780 (UMLS CUI [6,1])
C0332185 (UMLS CUI [6,2])
C4019044 (UMLS CUI [7,1])
C0332185 (UMLS CUI [7,2])
C0332185 (UMLS CUI [8,1])
C0995150 (UMLS CUI [8,2])
C0020205 (UMLS CUI [8,3])