Informed Consent
Item
1. provision of a signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male and female subjects 18 years of age and older at the time of screening
boolean
C0001779 (UMLS CUI [1])
Disease Progression | Status post Standard therapy Quantity
Item
3. subjects who progressed after receiving at least 2, but no more than 3, prior soc treatment lines
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Life Expectancy
Item
4. anticipated life expectancy >3 months at the time of screening
boolean
C0023671 (UMLS CUI [1])
Body Weight
Item
5. weight between 40 kg and 180 kg
boolean
C0005910 (UMLS CUI [1])
Colorectal Carcinoma
Item
6. histologically or cytologically confirmed diagnosis of crc
boolean
C0009402 (UMLS CUI [1])
Colorectal cancer metastatic Inappropriate Excision
Item
7. metastatic crc not amenable to surgical resection
boolean
C0948380 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
KRAS gene Mutation Status Known | NRAS gene Mutation Status Known
Item
8. known kras and nras mutation status (if unknown status for either of these genes, and no archival tissues is available, a fresh tumor biopsy will be made)
boolean
C1537502 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205309 (UMLS CUI [1,4])
C0809246 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
C0449438 (UMLS CUI [2,3])
C0205309 (UMLS CUI [2,4])
Measurable Disease Quantity
Item
9. at least 1 measurable lesion as defined by recist v1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
10. ecog ps of 0-2
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
11. adequate hematological function, defined as:
boolean
C0221130 (UMLS CUI [1])
Platelet Count measurement
Item
1. platelet count ≥ 100,000/μl
boolean
C0032181 (UMLS CUI [1])
Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
2. prothrombin time and activated partial thromboplastin time (aptt) < 1.5 times the upper limit of normal (uln)
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Absolute neutrophil count
Item
3. absolute neutrophil count (anc) ≥ 1,000/μl
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement | Requirement Absent Transfusion
Item
4. hemoglobin ≥ 9 g/dl, without the need for transfusion in the 2 weeks prior to screening
boolean
C0518015 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005841 (UMLS CUI [2,3])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
12. adequate renal function, defined as serum creatinine ≤ 2.0 times uln and creatinine clearance > 50 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function
Item
13. adequate liver function, defined as:
boolean
C0232741 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
1. aspartate aminotransferase (ast) and alanine aminotransferase (alt)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
≤ 2.5 times uln for subjects without liver metastases, or ≤ 5 times uln in the presence of liver metastases
boolean
C0494165 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0494165 (UMLS CUI [2])
Serum total bilirubin measurement | Exception Gilbert Disease
Item
2. bilirubin ≤ 2.0 times uln, unless subject has known gilbert's syndrome
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
Venous access patent
Item
14. adequate venous access
boolean
C3164222 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Contraception, Barrier | Vaginal contraceptive diaphragm | Spermicidal foam or jelly | Gender Partner Male Condom | Contraceptives, Oral | Contraceptive patch | Intrauterine Devices
Item
15. for female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control measures, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or [for male partner] condom) throughout the course of the study and for at least 90 days after the last administration of bax69. other acceptable contraceptive measures include birth control pills/patches or intrauterine devices
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0004764 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C3843423 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
C0009653 (UMLS CUI [6,3])
C0009905 (UMLS CUI [7])
C2985284 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
Gender Contraceptive methods | Barrier Contraception Quantity | Condoms, Male | Spermicidal foam or jelly | Partner Vaginal contraceptive diaphragm | Partner Spermicidal foam or jelly | Partner Oral Contraceptives | Partner Contraceptive patch | Partner Intrauterine Devices | Gender Sperm donation Absent
Item
16. for male subjects, the subject must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and [for the female partner] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of bax69
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0009653 (UMLS CUI [3])
C3843423 (UMLS CUI [4])
C0682323 (UMLS CUI [5,1])
C0042241 (UMLS CUI [5,2])
C0682323 (UMLS CUI [6,1])
C3843423 (UMLS CUI [6,2])
C0682323 (UMLS CUI [7,1])
C0009905 (UMLS CUI [7,2])
C0682323 (UMLS CUI [8,1])
C2985284 (UMLS CUI [8,2])
C0682323 (UMLS CUI [9,1])
C0021900 (UMLS CUI [9,2])
C0079399 (UMLS CUI [10,1])
C0871414 (UMLS CUI [10,2])
C0332197 (UMLS CUI [10,3])
Protocol Compliance
Item
17. subject is willing and able to comply with the requirements of the protocol.
boolean
C0525058 (UMLS CUI [1])
CNS metastases
Item
1. known central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Prostate carcinoma Advanced Locally | Exception Ductal carcinoma in situ of breast | Exception Carcinoma in situ of uterine cervix | Exception Superficial carcinoma of urinary bladder
Item
2. prior malignancy(s) within the past 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin, locally advanced prostate cancer, ductal carcinoma in situ of breast, in situ cervical carcinoma and superficial bladder cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0007124 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1336527 (UMLS CUI [7,2])
panitumumab | Neoplasm KRAS gene Wild Type | Neoplasm NRAS gene Wild Type
Item
3. prior treatment with panitumumab for subjects with kras and nras wt tumor
boolean
C0879427 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1537502 (UMLS CUI [2,2])
C1883559 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0809246 (UMLS CUI [3,2])
C1883559 (UMLS CUI [3,3])
Prior Therapy | Adverse event Residual CTCAE Grades
Item
4. residual ae from previous treatment > grade 1
boolean
C1514463 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Intolerance to Fluoropyrimidine | Neoplasm KRAS Gene Mutation | Neoplasm NRAS gene mutation
Item
5. prior intolerance to fluoropyrimidine for subjects with kras or nras mut tumor
boolean
C1744706 (UMLS CUI [1,1])
C0596581 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1517649 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C1513808 (UMLS CUI [3,2])
Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Unstable | Pharmaceutical Preparations Required | At risk Polymorphic ventricular tachycardia | Hypokalemia | Family history of long QT syndrome
Item
6. myocardial infarction within 6 months prior to c1d1, and/or prior diagnoses of congestive heart failure (new york heart association class iii or iv), unstable angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or long qt syndrome)
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C1444641 (UMLS CUI [6,1])
C0344432 (UMLS CUI [6,2])
C0020621 (UMLS CUI [7])
C3839836 (UMLS CUI [8])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
7. uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmhg and/or diastolic blood pressure ≥ 100 mmhg confirmed upon repeated measures
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Left ventricular ejection fraction Echocardiography
Item
8. lvef < 40% as determined by echocardiogram performed at screening or within 90 days prior to c1d1
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
ECG QT interval | ECG QTc interval
Item
9. qt/qtc interval > 450 msec, as determined by screening ecg performed no earlier than 1 week before c1d1
boolean
C0429028 (UMLS CUI [1])
C2216079 (UMLS CUI [2])
Cancer treatment | Chemotherapy | Therapeutic radiology procedure | Antibody therapy | Molecular Targeted Therapy | Retinoid therapy of cancer | Hormone Therapy
Item
10. prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within 4 weeks prior to c1d1.
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0281176 (UMLS CUI [4])
C2699893 (UMLS CUI [5])
C0598926 (UMLS CUI [6])
C0279025 (UMLS CUI [7])
Major surgery
Item
11. major surgery within 4 weeks prior to c1d1
boolean
C0679637 (UMLS CUI [1])
Inflamed joint | Arthritis | Immune System Diseases Involving Joints
Item
12. active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
boolean
C0574941 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0021053 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0022417 (UMLS CUI [3,3])
Communicable Disease Involving Antibiotics Intravenous
Item
13. active infection involving iv antibiotics within 2 weeks prior to c1d1
boolean
C0009450 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
Hepatitis B | Hepatitis C | Tuberculosis
Item
14. known history of, or active hepatitis b virus (hbv), hepatitis c virus (hcv) or active tuberculosis
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
HIV-1 infection | HIV-2 infection | Immunodeficiency disease
Item
15. known history of human immunodeficiency virus (hiv) type 1/2 or other immunodeficiency disease
boolean
C2363741 (UMLS CUI [1])
C0854094 (UMLS CUI [2])
C0021051 (UMLS CUI [3])
Vaccines, Attenuated
Item
16. subject has received a live vaccine within 4 weeks prior to c1d1
boolean
C0042211 (UMLS CUI [1])
Hypersensitivity Recombinant Proteins CHO Cells
Item
17. known hypersensitivity to any component of recombinant protein production by cho cells
boolean
C0020517 (UMLS CUI [1,1])
C0034861 (UMLS CUI [1,2])
C0085080 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Scheduled | Investigational New Drugs | Investigational Medical Device
Item
18. exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to c1d1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
C0013230 (UMLS CUI [5])
C2346570 (UMLS CUI [6])
Breast Feeding | Breast Feeding intended
Item
19. subject is nursing or intends to begin nursing during the course of the study
boolean
C0006147 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
Disease compromises Study Subject Participation Status | Laboratory test result abnormal compromises Study Subject Participation Status | Abnormal blood test compromises Study Subject Participation Status | ECG abnormal compromises Study Subject Participation Status | Disease At risk Study Subject | Laboratory test result abnormal At risk Study Subject | Abnormal blood test At risk Study Subject | ECG abnormal At risk Study Subject | Disease Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Abnormal blood test Interferes with Research results | ECG abnormal Interferes with Research results
Item
20. any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ecg), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study
boolean
C0012634 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0854146 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0522055 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0681850 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0681850 (UMLS CUI [6,3])
C0854146 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C0681850 (UMLS CUI [7,3])
C0522055 (UMLS CUI [8,1])
C1444641 (UMLS CUI [8,2])
C0681850 (UMLS CUI [8,3])
C0012634 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0683954 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0683954 (UMLS CUI [10,3])
C0854146 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0683954 (UMLS CUI [11,3])
C0522055 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
Study Subject Family member Investigator | Study Subject Employee Investigator
Item
21. subject is a family member or employee of the investigator
boolean
C0681850 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C0599987 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])