ID

18376

Description

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00359190

Link

https://clinicaltrials.gov/show/NCT00359190

Keywords

Versions (1)
  1. 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 NCT00359190

English

Eligibility Neoplasms, Breast NCT00359190

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical labs are within acceptable ranges.
Description

Laboratory Results Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
a histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
Description

Therapy naive Breast Carcinoma | Tumor size | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0475440
UMLS CUI [3]
C0005558
at least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
females must meet certain criteria specified in protocol.
Description

Gender | Inclusion criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C2348563
ability to swallow and retain oral medication.
Description

Able to swallow oral medication | oral medication Retain Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0085732
ability to follow and understand directions.
Description

Follow directions Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C1720622
UMLS CUI [1,2]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
medically unfit by the doctor as a result of the medical interview or physicals.
Description

Medically unfit | patient interview | Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C3841806
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
received treatment of an investigational drug within 4 weeks of study start.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
currently receiving treatment with prohibited meds listed in protocol.
Description

Illicit drug use Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C2348563
had major surgery in previous 2 weeks.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
had prior radiation therapy to the chest to treat this incidence of breast cancer.
Description

History of radiation therapy to chest Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C4038799
UMLS CUI [1,2]
C0678222
hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
Description

Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs | Idiosyncrasy Pharmaceutical Preparations Related Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013230
has a malabsorption syndrome.
Description

Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0024523
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Similar models

Eligibility Neoplasms, Breast NCT00359190

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Laboratory Results Acceptable
Item
clinical labs are within acceptable ranges.
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Therapy naive Breast Carcinoma | Tumor size | Biopsy
Item
a histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
boolean
C0919936 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Gender | Inclusion criteria Study Protocol
Item
females must meet certain criteria specified in protocol.
boolean
C0079399 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Able to swallow oral medication | oral medication Retain Ability
Item
ability to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Follow directions Ability
Item
ability to follow and understand directions.
boolean
C1720622 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female who is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medically unfit | patient interview | Physical Examination
Item
medically unfit by the doctor as a result of the medical interview or physicals.
boolean
C3841806 (UMLS CUI [1])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Investigational New Drugs
Item
received treatment of an investigational drug within 4 weeks of study start.
boolean
C0013230 (UMLS CUI [1])
Illicit drug use Study Protocol
Item
currently receiving treatment with prohibited meds listed in protocol.
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
major surgery
Item
had major surgery in previous 2 weeks.
boolean
C0679637 (UMLS CUI [1])
History of radiation therapy to chest Breast Carcinoma
Item
had prior radiation therapy to the chest to treat this incidence of breast cancer.
boolean
C4038799 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs | Idiosyncrasy Pharmaceutical Preparations Related Investigational New Drugs
Item
hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Malabsorption Syndrome
Item
has a malabsorption syndrome.
boolean
C0024523 (UMLS CUI [1])
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