ID

44190

Beschrijving

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document is for documentation of eligibility criteria at the screening visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Trefwoorden

Versies (2)
  1. 16-03-20 16-03-20 - Christian Arras
  2. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

Engels

Eligibility criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Beschrijving

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschrijving

If No, please select all boxes corresponding to violations of any inclusion/exclusion criteria.

Datatype

text

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Beschrijving

Inclusion criteria

Alias
UMLS CUI-1
C1512693
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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C0027627
UMLS CUI [2,3]
C0162789
UMLS CUI [3,1]
C1960398
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0299250
UMLS CUI [4,1]
C0280100
UMLS CUI [4,2]
C0006142
UMLS CUI [4,3]
C0027627
UMLS CUI [4,4]
C0205269
UMLS CUI [5,1]
C0280100
UMLS CUI [5,2]
C0006142
UMLS CUI [5,3]
C0027627
UMLS CUI [5,4]
C0087111
UMLS CUI [5,5]
C0205540
UMLS CUI [5,6]
C0332197
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0006142
UMLS CUI [6,3]
C0027627
UMLS CUI [6,4]
C1506770
UMLS CUI [6,5]
C0920425
UMLS CUI [6,6]
C1548635
Male and female, at least 18 years of age and not greater than 75 years of age.
Beschrijving

Gender, Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
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.
Beschrijving

Contraception methods: Double-barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm). Complete abstinence from sexual intercourse from two weeks prior to administration of the study drug, throughout the active study treatment period. Vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female.

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0600109
UMLS CUI [3]
C0427780
Is able to swallow and retain oral medication.
Beschrijving

Ability to swallow and retain oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
ECOG performance status 0 to 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
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).
Beschrijving

bone marrow, physiological aspects, hemoglobin measurement, Granulocyte count, blood platelets

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0857490
UMLS CUI [4]
C0005821
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.
Beschrijving

Estimation of creatinine clearance based on Cockcroft-Gault formula, INR, bilirubin total measurement, AST

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201836
Has a left ventricular ejection fraction (LVEF) within the normal institutional range based on ECHO or MUGA.
Beschrijving

LVEF measurement base on ECHO or MUGA

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
Life expectancy of ≥12 weeks
Beschrijving

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beschrijving

Capability of giving informed consent, Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2698977
UMLS CUI [2]
C0525058
Exclusion criteria
Beschrijving

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Is pregnant or lactating.
Beschrijving

Pregnancy, breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the colon, stomach or small bowel.
Beschrijving

malabsorption syndrome, disease affecting gastrointestinal function, resection of colon, stomach or small bowel

Datatype

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C4069040
UMLS CUI [4,1]
C0038351
UMLS CUI [4,2]
C0728940
UMLS CUI [5]
C0192601
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).
Beschrijving

active hepatic disease, current biliary disease, except for Gilbert's syndrome, asymptomatic gallstones, liver metastases or patient with assessed stable chronic liver disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C2707252
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C2707252
UMLS CUI [2,2]
C0016977
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0017551
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0008350
UMLS CUI [4,3]
C0231221
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0494165
UMLS CUI [6,1]
C0332300
UMLS CUI [6,2]
C0341439
UMLS CUI [6,3]
C0205360
UMLS CUI [6,4]
C0022423
UMLS CUI [6,5]
C0008961
Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease.
Beschrijving

Subjects with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants for at least 28 days prior to the first dose of study drug.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0231220
UMLS CUI [3,2]
C0751297
UMLS CUI [4,1]
C0205318
UMLS CUI [4,2]
C0751297
Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
Beschrijving

medically unfit as a result of medical interview, physical exam or screening investigation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0683518
UMLS CUI [2,1]
C3841806
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3841806
UMLS CUI [3,2]
C0281974
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].
Beschrijving

hypersensitivity or idiosyncrasy to procedure-related pharmaceutical preparations such as gefitinib, erlotinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2924519
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2924519
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1122962
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1135135
UMLS CUI [5,1]
C0231191
UMLS CUI [5,2]
C1122962
UMLS CUI [6,1]
C0231191
UMLS CUI [6,2]
C1135135
Has received treatment with any investigational drug in the previous four weeks.
Beschrijving

treatment with experimental drug, recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
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.
Beschrijving

Note: Any ongoing potentially reversible toxicity from prior anti-cancer therapy that is > Grade 1 or any toxicity from prior anti-cancer therapy that is progressing in severity will render the subject ineligible.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0920425
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0005527
UMLS CUI [4,2]
C0920425
UMLS CUI [4,3]
C0332185
UMLS CUI [5,1]
C0002475
UMLS CUI [5,2]
C0332185
Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list
Beschrijving

Prohibited medication list: CYP3A4 Inducers: rifampicin antibiotics, anticonvulsants, antiretrovirals, glucocorticoids (oral only); CYP3A4 Inhibitors: antibiotics, antifungals, antiretrovirals, calcium channel blockers, antidepressants, gastrointestinal agents, fruit juices, amiodarone; Miscellaneous: antacids, herbal supplements (ginkgo biloba, kava, grape seed, valerian, ginseng, echinacea, evening primrose oil

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0683610
UMLS CUI [1,3]
C1290952
Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Beschrijving

physiological, familial, sociological or geographical conditions, protocol compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205463
UMLS CUI [1,2]
C1521761
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0525058
Has inadequate venous access for protocol-related blood draws.
Beschrijving

inadequate venous access

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750164
UMLS CUI [1,2]
C0205412
Clinically significant electrocardiogram(ECG) abnormality including baseline QTc prolongation >480msec.
Beschrijving

ECG abnormality, baseline QTc prolongation

Datatype

boolean

Alias
UMLS CUI [1]
C1969409
UMLS CUI [2]
C0522055
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Beschrijving

heparin hypersensitivity, heparin-induces thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0020517
UMLS CUI [2]
C0272285
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.
Beschrijving

recent consumption of red wine, seville oranges, grapefruits, grapefruit juice, kumquats, pummelos, exotic citrus fruits or grapefruit hybrids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0452456
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0349371
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0330922
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C0453281
UMLS CUI [5,2]
C0332185
UMLS CUI [6,1]
C1006780
UMLS CUI [6,2]
C0332185
UMLS CUI [7,1]
C4019044
UMLS CUI [7,2]
C0332185
UMLS CUI [8,1]
C0332185
UMLS CUI [8,2]
C0995150
UMLS CUI [8,3]
C0020205
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Similar models

Eligibility criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Did the subject meet all the entry criteria?
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
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])
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