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

Lien

https://clinicaltrials.gov/show/NCT00359190

Mots-clés

Versions (1)
  1. 2016-11-02 2016-11-02 -
Téléchargé le

2 november 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Neoplasms, Breast NCT00359190

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Eligibility Neoplasms, Breast NCT00359190

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Laboratory Results Acceptable

Type de données

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

Type de données

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

Type de données

boolean

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

Gender | Inclusion criteria Study Protocol

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Illicit drug use Study Protocol

Type de données

boolean

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

major surgery

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1]
C0024523
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Similar models

Eligibility Neoplasms, Breast NCT00359190

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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