Gender | Age
Item
1. females of age ≥18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Triple Negative Breast Neoplasm metastatic | Triple Negative Breast Neoplasm Any
Item
2. histologically documented metastatic triple negative breast cancer (any triple negative breast cancer for phase i)
boolean
C3539878 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C3539878 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Chemotherapy Regimen Quantity Advanced disease
Item
3. two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens for phase i)
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
ECOG performance status
Item
4. ecog performance score of 1 or less
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
5. presence of measurable disease by recist 1.1 criteria (not for the phase i portion)
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
6. ability to understand and the willingness to sign a written informed consent document (icd)
boolean
C0021430 (UMLS CUI [1])
Toxicity Due to Prior Therapy | Recovery Full CTCAE Grades
Item
7. full recovery from all prior treatment toxicities to common terminology criteria for adverse events (ctcae v.4) grade ≤ 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C0443225 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Prior Chemotherapy | Antineoplastic Biological Agent | Antineoplastic Agents Targeted
Item
1. prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
boolean
C1514457 (UMLS CUI [1])
C4329349 (UMLS CUI [2])
C0003392 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
Prior radiation therapy
Item
2. prior radiation therapy within 6 weeks of study drug administration
boolean
C0279134 (UMLS CUI [1])
CNS metastases | Meningeal Carcinomatosis
Item
3. subject with known active cns metastases and/or carcinomatous meningitis. however, subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases (2) off steroids that are used to minimize surrounding brain edema.
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
gemcitabine | Platinum-based Drug
Item
4. prior therapy with gemcitabine or a platinum agent (not for the phase i part)
boolean
C0045093 (UMLS CUI [1])
C2266918 (UMLS CUI [2])
Cyclin-Dependent Kinase Inhibitor Agents | Flavones Derivative
Item
5. prior therapy with a cdk/cyclin inhibitor or any flavones derivative
boolean
C1511576 (UMLS CUI [1])
C0016219 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
Q-T interval corrected based on Fridericia formula
Item
6. qtc interval >450 msec (using fridericia's formula)
boolean
C4037594 (UMLS CUI [1])
Acute illness | Diabetic - poor control | Heart Disease Symptomatic | Heart Disease Uncontrolled | Coronary Artery Disease | Cardiac Arrhythmia | Congestive heart failure | Illness Inducing Risk factors
Item
7. any acute illness including uncontrolled diabetes, symptomatic or otherwise uncontrolled cardiac disease (coronary artery disease, arrhythmias, congestive heart failure) or other illness that in the judgment of the investigator would introduce additional medical risks
boolean
C4061114 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1956346 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0221423 (UMLS CUI [8,1])
C0205263 (UMLS CUI [8,2])
C0035648 (UMLS CUI [8,3])
Visceral Crisis | Liver disease Extensive | Involvement with Parenchymal Tissue Percentage | Lymphangitis carcinomatosa Pulmonary
Item
8. visceral crisis including extensive liver disease with>50% parenchymal involvement or lymphangitic pulmonary disease
boolean
C4527413 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C4277702 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0238258 (UMLS CUI [4,1])
C2709248 (UMLS CUI [4,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated
Item
9. history of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, or in situ breast cancer
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])
C0553723 (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])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Life Expectancy
Item
10. expected survival of less than 3 months
boolean
C0023671 (UMLS CUI [1])
Hemoglobin measurement
Item
11. hemoglobin <9.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
12. absolute neutrophil count <1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
13. platelet count <100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
14. alanine aminotransferase (alt) and aspartate aminotransferase (ast) >3 ×
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
ID.22
Item
institutional upper limit of normal (uln)
boolean
Elevated total bilirubin
Item
15. total bilirubin, >1.5 × institutional uln
boolean
C0741494 (UMLS CUI [1])
Creatinine measurement, serum
Item
16. serum creatinine >1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
HIV Infection | Tuberculosis | Hepatitis C | Hepatitis B
Item
17. subjects with known infection with human immunodeficiency virus (hiv), tuberculosis, hepatitis c or hepatitis b
boolean
C0019693 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
18. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
19. women of childbearing potential not willing to use approved methods of contraception after signing the icd, during the entire study and for at least 4 weeks after completion of study or following withdrawal from the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])