ID

16216

Description

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

Lien

https://clinicaltrials.gov/show/NCT00126451

Mots-clés

Versions (1)
  1. 05/07/2016 05/07/2016 -
Téléchargé le

5 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00126451

Anglais

Eligibility Breast Cancer NCT00126451

1 Formulaires  
Inclusion Criteria
Description

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
Description

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

Type de données

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.
Description

Recurrent disease Following Chemotherapy Regimen | Refractory Disease Following Chemotherapy Regimen

Type de données

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
Description

Measurable lesion Assessment Positron-Emission Tomography

Type de données

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
Description

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

Type de données

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
Description

Chemotherapy

Type de données

boolean

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

Contraceptive methods agreement

Type de données

boolean

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

Exclusion Criteria

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

Histone deacetylase inhibitor

Type de données

boolean

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

Investigational New Drugs

Type de données

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.
Description

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

Type de données

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.
Description

HIV Infection | Hepatitis B | Hepatitis C

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

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

Hypersensitivity Investigational New Drug Component

Type de données

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