ID

44249

Descripción

Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents; ODM derived from: https://clinicaltrials.gov/show/NCT00790816

Link

https://clinicaltrials.gov/show/NCT00790816

Palabras clave

Versiones (2)
  1. 12/7/18 12/7/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Neoplasms, Breast NCT00790816

Inglés

Eligibility Neoplasms, Breast NCT00790816

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participation in a phase i lapatinib trial that has met its study objectives.
Descripción

Study Subject Participation Status | Trial Phase | Lapatinib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1710475
UMLS CUI [3]
C1506770
ability to understand and provide written informed consent to participate in this study.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male or female greater than or equal to 18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
a female subject is eligible to participate if she is of:
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
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.
Descripción

Childbearing Potential Absent | Premenopausal state Tubal Ligation | Premenopausal state Hysterectomy | Postmenopausal state | Amenorrhea Spontaneous | Hormone replacement therapy Contraceptive methods | Menopausal Status Uncertain Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0520483
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0020699
UMLS CUI [4]
C0232970
UMLS CUI [5,1]
C0002453
UMLS CUI [5,2]
C0205359
UMLS CUI [6,1]
C0282402
UMLS CUI [6,2]
C0700589
UMLS CUI [7,1]
C3829127
UMLS CUI [7,2]
C0087130
UMLS CUI [7,3]
C0700589
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.
Descripción

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

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

Lapatinib Discontinuation Permanent | Etiology Intolerance to Lapatinib | Etiology Treatment failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0205355
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1744706
UMLS CUI [2,3]
C1506770
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0162643
is a pregnant or lactating female.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

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 baseline investigations.
Descripción

Study Subject Participation Status Medically unfit | Patient interview | Physical Examination | Baseline Investigation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841806
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
UMLS CUI [4,1]
C1442488
UMLS CUI [4,2]
C1261322
currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
Descripción

Pharmaceutical Preparations Illicit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332266
has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.
Descripción

Heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
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).
Descripción

Liver disease | Gall Bladder Disease | Exception Gilbert Disease | Exception Kidney Calculi Asymptomatic | Exception Secondary malignant neoplasm of liver | Exception Chronic liver disease Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0016977
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0017551
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0022650
UMLS CUI [4,3]
C0231221
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0494165
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0341439
UMLS CUI [6,3]
C0205360
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Similar models

Eligibility Neoplasms, Breast NCT00790816

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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