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])
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])