ID

19746

Beskrivning

A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025); ODM derived from: https://clinicaltrials.gov/show/NCT00251589

Länk

https://clinicaltrials.gov/show/NCT00251589

Nyckelord

Versioner (1)
  1. 2017-01-25 2017-01-25 -
Uppladdad den

25 januari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00251589

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT00251589

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (nsclc) who have failed at least one prior treatment for nsclc.
Beskrivning

Age | Non-Small Cell Lung Carcinoma | Therapeutic procedure Quantity failed

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007131
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231175
patients must have proven disease by ct scan or mri.
Beskrivning

Disease Proven X-Ray Computed Tomography | Magnetic Resonance Imaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0456369
UMLS CUI [1,3]
C0040405
UMLS CUI [2]
C0024485
patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
Beskrivning

Chemotherapy Malignant Neoplasms Status post | Operative Surgical Procedures Status post | Investigational New Drugs Status post

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0231290
UMLS CUI [1,4]
C0231290
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0231290
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0231290
patients must be 2 weeks out from radiation therapy.
Beskrivning

Therapeutic radiology procedure Status post

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0231290
at screening the patient must have normal lab results and can not be pregnant.
Beskrivning

Normal Laboratory Test Result | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0438214
UMLS CUI [2]
C0032961
women and men must agree to practice adequate birth control during the study.
Beskrivning

Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
patient has the ability to understand and sign the consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient had prior treatment with vorinostat or erlotinib.
Beskrivning

Vorinostat | erlotinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0672708
UMLS CUI [2]
C1135135
patient has any of the following conditions: active infections including hepatitis b or c, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.
Beskrivning

Communicable Diseases | Hepatitis B | Hepatitis C | Metastatic malignant neoplasm to brain Unstable | Deglutition Disorders | HEART PROBLEM | Eye Abnormalities Significant | Substance Use Disorders | Mental disorders | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C0443343
UMLS CUI [5]
C0011168
UMLS CUI [6]
C0795691
UMLS CUI [7,1]
C0015393
UMLS CUI [7,2]
C0750502
UMLS CUI [8]
C0038586
UMLS CUI [9]
C0004936
UMLS CUI [10]
C0032961
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00251589

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Small Cell Lung Carcinoma | Therapeutic procedure Quantity failed
Item
males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (nsclc) who have failed at least one prior treatment for nsclc.
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Disease Proven X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
patients must have proven disease by ct scan or mri.
boolean
C0012634 (UMLS CUI [1,1])
C0456369 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0024485 (UMLS CUI [2])
Chemotherapy Malignant Neoplasms Status post | Operative Surgical Procedures Status post | Investigational New Drugs Status post
Item
patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C0231290 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
Therapeutic radiology procedure Status post
Item
patients must be 2 weeks out from radiation therapy.
boolean
C1522449 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
Normal Laboratory Test Result | Pregnancy
Item
at screening the patient must have normal lab results and can not be pregnant.
boolean
C0438214 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Gender Contraceptive methods
Item
women and men must agree to practice adequate birth control during the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
patient has the ability to understand and sign the consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vorinostat | erlotinib
Item
patient had prior treatment with vorinostat or erlotinib.
boolean
C0672708 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
Communicable Diseases | Hepatitis B | Hepatitis C | Metastatic malignant neoplasm to brain Unstable | Deglutition Disorders | HEART PROBLEM | Eye Abnormalities Significant | Substance Use Disorders | Mental disorders | Pregnancy
Item
patient has any of the following conditions: active infections including hepatitis b or c, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.
boolean
C0009450 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0220650 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0011168 (UMLS CUI [5])
C0795691 (UMLS CUI [6])
C0015393 (UMLS CUI [7,1])
C0750502 (UMLS CUI [7,2])
C0038586 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0032961 (UMLS CUI [10])
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