ID

16216

Beskrivning

A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00126451

Länk

https://clinicaltrials.gov/show/NCT00126451

Nyckelord

Versioner (1)
  1. 2016-07-05 2016-07-05 -
Uppladdad den

5 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00126451

Engelsk

Eligibility Breast Cancer NCT00126451

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
Beskrivning

Age | Breast adenocarcinoma | Colorectal Carcinoma | Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0858252
UMLS CUI [3]
C0009402
UMLS CUI [4]
C0007131
patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
Beskrivning

Recurrent disease Following Chemotherapy Regimen | Refractory Disease Following Chemotherapy Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0392920
has a measurable, positron emission tomography (pet) assessable lesion
Beskrivning

Measurable lesion Assessment Positron-Emission Tomography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0032743
adequate blood, liver, bone marrow and kidney functions
Beskrivning

Hematologic function | Liver function | Bone Marrow function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [4]
C0232804
has not received any chemotherapy for at least 4 weeks prior to entry in this study
Beskrivning

Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
agrees to take adequate measures to prevent pregnancy.
Beskrivning

Contraceptive methods agreement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0680240
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has had prior treatment with histone deacetylase (hdac) inhibitor.
Beskrivning

Histone deacetylase inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1512474
patient has had treatment with investigational agents within the last 30 days.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patient has active infection or had intravenous (iv) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
Beskrivning

Communicable Diseases | Intravenous antibiotic therapy | Antiviral Agents | Antifungal Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0559680
UMLS CUI [3]
C0003451
UMLS CUI [4]
C0003308
patient has hiv, hepatitis b or hepatitis c infection.
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
patient is pregnant or lactating.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has allergy to any component of the study drug.
Beskrivning

Hypersensitivity Investigational New Drug Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
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Similar models

Eligibility Breast Cancer NCT00126451

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Breast adenocarcinoma | Colorectal Carcinoma | Non-Small Cell Lung Carcinoma
Item
patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
boolean
C0001779 (UMLS CUI [1])
C0858252 (UMLS CUI [2])
C0009402 (UMLS CUI [3])
C0007131 (UMLS CUI [4])
Recurrent disease Following Chemotherapy Regimen | Refractory Disease Following Chemotherapy Regimen
Item
patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
boolean
C0277556 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Measurable lesion Assessment Positron-Emission Tomography
Item
has a measurable, positron emission tomography (pet) assessable lesion
boolean
C1513041 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Hematologic function | Liver function | Bone Marrow function | Renal function
Item
adequate blood, liver, bone marrow and kidney functions
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0232804 (UMLS CUI [4])
Chemotherapy
Item
has not received any chemotherapy for at least 4 weeks prior to entry in this study
boolean
C0392920 (UMLS CUI [1])
Contraceptive methods agreement
Item
agrees to take adequate measures to prevent pregnancy.
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Histone deacetylase inhibitor
Item
patient has had prior treatment with histone deacetylase (hdac) inhibitor.
boolean
C1512474 (UMLS CUI [1])
Investigational New Drugs
Item
patient has had treatment with investigational agents within the last 30 days.
boolean
C0013230 (UMLS CUI [1])
Communicable Diseases | Intravenous antibiotic therapy | Antiviral Agents | Antifungal Agents
Item
patient has active infection or had intravenous (iv) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
boolean
C0009450 (UMLS CUI [1])
C0559680 (UMLS CUI [2])
C0003451 (UMLS CUI [3])
C0003308 (UMLS CUI [4])
HIV Infection | Hepatitis B | Hepatitis C
Item
patient has hiv, hepatitis b or hepatitis c infection.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drug Component
Item
patient has allergy to any component of the study drug.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
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