ID

41190

Beskrivning

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01594398

Länk

https://clinicaltrials.gov/show/NCT01594398

Nyckelord

Versioner (1)
  1. 2020-07-08 2020-07-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 juli 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT01594398

Engelsk

Eligibility Lung Cancer NCT01594398

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer patients only
Beskrivning

Breast Carcinoma Patients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0030705
postmenopausal female patients
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
histologically or cytologically confirmed er+ breast cancer at initial diagnosis and now has current disease progression and is a candidate to receive exemestane
Beskrivning

Estrogen receptor positive breast cancer | Disease Progression | Patient Appropriate Exemestane

Datatyp

boolean

Alias
UMLS CUI [1]
C2938924
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0851344
nsclc patients only:
Beskrivning

Non-Small Cell Lung Carcinoma Patients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0030705
cytologically or histologically confirmed nsclc of stage iiib or iv
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
received 1 to 2 prior chemotherapy or chemoradiotherapy regimens for advanced nsclc (excluding erlotinib and valproic acid) and now has disease progression and is a candidate to receive erlotinib
Beskrivning

Prior Chemotherapy Quantity Advanced Lung Non-Small Cell Carcinoma | Chemoradiotherapy Quantity Advanced Lung Non-Small Cell Carcinoma | Exception Erlotinib | Exception Valproic acid | Disease Progression | Patient Appropriate Erlotinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C5206378
UMLS CUI [2,1]
C0436307
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C5206378
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1135135
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0042291
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1548787
UMLS CUI [6,3]
C1135135
all patients:
Beskrivning

Patients All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0444868
age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient must have the following laboratory parameters at study screening: hemoglobin
Beskrivning

Laboratory Results Required | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
UMLS CUI [2]
C0518015
≥ 9.0 g/dl; unsupported platelets ≥ 100.0 10-9/l; anc ≥ 2.0 x 10-9/l; creatinine less than 2.5 times the upper limit of normal for the institution; ast and alanine transaminase (alt) < 2.5 times the upper limit of normal for the institution
Beskrivning

Platelet Count measurement | Absolute neutrophil count | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
patients may have a history of brain metastasis as long as certain criteria are met
Beskrivning

Metastatic malignant neoplasm to brain | Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has rapidly progressive or life-threatening metastases.
Beskrivning

Neoplasm Metastasis Rapidly progressive | Neoplasm Metastasis Life Threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1838681
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C2826244
patient has had previous treatment with entinostat or any other hdac inhibitor including valproic acid
Beskrivning

entinostat | Histone deacetylase inhibitor | valproic acid

Datatyp

boolean

Alias
UMLS CUI [1]
C2743752
UMLS CUI [2]
C1512474
UMLS CUI [3]
C0042291
patient has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator, such as but not limited to:
Beskrivning

Comorbidity Excludes Treatment Compliance | Comorbidity At risk Patient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
mi or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, new york heart association (nyha) class iii or iv disease and a qtc interval > 0.47 seconds.
Beskrivning

Myocardial Infarction | Thromboembolism | Angina Pectoris Severe | Angina, Unstable | Disease New York Heart Association Classification | Prolonged QTc interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0040038
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1275491
UMLS CUI [6]
C1560305
uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection.
Beskrivning

Heart failure Uncontrolled | Uncontrolled hypertension | Diabetic - poor control | Sepsis Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0421258
UMLS CUI [4,1]
C0243026
UMLS CUI [4,2]
C0205318
patients with another active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [cin / cervical carcinoma in situ] or melanoma in situ). prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
Beskrivning

Cancer Other | Exception Basal cell carcinoma Treated | Exception Cervical Intraepithelial Neoplasia Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant melanoma in situ Treated | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0206708
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0854696
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
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Similar models

Eligibility Lung Cancer NCT01594398

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Patients
Item
breast cancer patients only
boolean
C0678222 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Postmenopausal state
Item
postmenopausal female patients
boolean
C0232970 (UMLS CUI [1])
Estrogen receptor positive breast cancer | Disease Progression | Patient Appropriate Exemestane
Item
histologically or cytologically confirmed er+ breast cancer at initial diagnosis and now has current disease progression and is a candidate to receive exemestane
boolean
C2938924 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0851344 (UMLS CUI [3,3])
Non-Small Cell Lung Carcinoma Patients
Item
nsclc patients only:
boolean
C0007131 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
cytologically or histologically confirmed nsclc of stage iiib or iv
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prior Chemotherapy Quantity Advanced Lung Non-Small Cell Carcinoma | Chemoradiotherapy Quantity Advanced Lung Non-Small Cell Carcinoma | Exception Erlotinib | Exception Valproic acid | Disease Progression | Patient Appropriate Erlotinib
Item
received 1 to 2 prior chemotherapy or chemoradiotherapy regimens for advanced nsclc (excluding erlotinib and valproic acid) and now has disease progression and is a candidate to receive erlotinib
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C5206378 (UMLS CUI [1,3])
C0436307 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C5206378 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1135135 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0042291 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5])
C0030705 (UMLS CUI [6,1])
C1548787 (UMLS CUI [6,2])
C1135135 (UMLS CUI [6,3])
Patients All
Item
all patients:
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Laboratory Results Required | Hemoglobin measurement
Item
patient must have the following laboratory parameters at study screening: hemoglobin
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
Platelet Count measurement | Absolute neutrophil count | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
≥ 9.0 g/dl; unsupported platelets ≥ 100.0 10-9/l; anc ≥ 2.0 x 10-9/l; creatinine less than 2.5 times the upper limit of normal for the institution; ast and alanine transaminase (alt) < 2.5 times the upper limit of normal for the institution
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
Metastatic malignant neoplasm to brain | Criteria Fulfill
Item
patients may have a history of brain metastasis as long as certain criteria are met
boolean
C0220650 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Neoplasm Metastasis Rapidly progressive | Neoplasm Metastasis Life Threatening
Item
patient has rapidly progressive or life-threatening metastases.
boolean
C0027627 (UMLS CUI [1,1])
C1838681 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
entinostat | Histone deacetylase inhibitor | valproic acid
Item
patient has had previous treatment with entinostat or any other hdac inhibitor including valproic acid
boolean
C2743752 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
C0042291 (UMLS CUI [3])
Comorbidity Excludes Treatment Compliance | Comorbidity At risk Patient
Item
patient has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator, such as but not limited to:
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
Myocardial Infarction | Thromboembolism | Angina Pectoris Severe | Angina, Unstable | Disease New York Heart Association Classification | Prolonged QTc interval
Item
mi or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, new york heart association (nyha) class iii or iv disease and a qtc interval > 0.47 seconds.
boolean
C0027051 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C1560305 (UMLS CUI [6])
Heart failure Uncontrolled | Uncontrolled hypertension | Diabetic - poor control | Sepsis Uncontrolled
Item
uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection.
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0243026 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Cervical Intraepithelial Neoplasia Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant melanoma in situ Treated | Exception Disease Free Duration
Item
patients with another active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [cin / cervical carcinoma in situ] or melanoma in situ). prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0206708 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0854696 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
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