Age | Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic | KRAS mutation | KRAS gene Wild Type | NRAS gene Mutation Unknown
Item
1. subject is ≥ 18 years old at the time of signing the informed consent form 2. subject has histological or cytological diagnosis of adenocarcinoma of the colon or rectum, with evidence of metastasis 3. subject has a known kras mutation status (mutated or wild-type). nras mutation status may be unknown.
boolean
C0001779 (UMLS CUI [1])
C4324497 (UMLS CUI [2])
C0149978 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C2747837 (UMLS CUI [4])
C1537502 (UMLS CUI [5,1])
C1883559 (UMLS CUI [5,2])
C0809246 (UMLS CUI [6,1])
C0596611 (UMLS CUI [6,2])
C0439673 (UMLS CUI [6,3])
Disease Progression | Status post Standard therapy
Item
4. subject has documented disease progression ≤ 2 months after the last administration of the last standard therapy.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
oxaliplatin | Adjuvant therapy | Disease Progression | Adjuvant therapy Complete | Prior Therapy | Prior Therapy Absent | fluoropyrimidine | oxaliplatin | irinotecan | Angiogenesis Inhibitors | bevacizumab | ziv-aflibercept | Malignant Neoplasm RAS Wild Type | Epidermal growth factor receptor inhibitor | cetuximab | panitumumab
Item
a. subjects treated with oxaliplatin in the adjuvant setting, should have progressed during or within 6 months of completion of adjuvant therapy 5. subject has either received prior treatment or was not a candidate for prior treatment, with fluoropyrimidine, oxaliplatin, irinotecan and an anti-vegf therapy (e.g. bevacizumab or ziv-aflibercept); and if ras wild-type tumors, an anti-egfr therapy (e.g. cetuximab or panitumumab).
boolean
C0069717 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C0677850 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0596581 (UMLS CUI [6])
C0069717 (UMLS CUI [7])
C0123931 (UMLS CUI [8])
C0596087 (UMLS CUI [9])
C0796392 (UMLS CUI [10])
C3485619 (UMLS CUI [11])
C0006826 (UMLS CUI [12,1])
C4331207 (UMLS CUI [12,2])
C1443775 (UMLS CUI [13])
C0995188 (UMLS CUI [14])
C0879427 (UMLS CUI [15])
ECOG performance status | Measurable Disease Radiography | Organ function
Item
6. subject has eastern cooperative oncology group performance status 0 or 1 7. subject has radiographically-documented measurable disease, as per response evaluation criteria in solid tumors version 1.1 criteria 8. subject has adequate organ functions, evidenced by the following:
boolean
C1520224 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C0678852 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
1. aspartate aminotransferase (sgot), alanine transaminase (sgpt) ≤ 2.5 × upper limit of normal range, or < 5 x upper limit of normal range if liver metastasis present
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Serum total bilirubin measurement
Item
2. total bilirubin ≤ 1.5 × upper limit of normal range
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum | Bone Marrow function
Item
3. creatinine ≤ 1.5 × upper limit of normal range 9. subject has adequate bone marrow function, evidenced by the following:
boolean
C0201976 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count
Item
1. absolute neutrophil count ≥ 1.5 × 109 cells/millimeters3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement | Independent of Transfusion | Platelet Transfusion Absent
Item
2. platelets ≥ 100 × 109 cells/millimeters3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
boolean
C0032181 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C1879316 (UMLS CUI [2,2])
C0086818 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hemoglobin measurement | Transfusion allowed | Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent
Item
3. hemoglobin ≥ 9 grams/decilitre (transfusion is permitted to fulfill this criterion) 10. females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
boolean
C0518015 (UMLS CUI [1])
C1879316 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3])
C0020699 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0278321 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
1. either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product therapy (including dose interruptions), and for 3 months following the last dose of investigational product; and
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Pregnancy Tests
Item
2. have a negative serum pregnancy test (β -human chorionic gonadotrophin) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. this applies even if the subject practices true abstinence* from heterosexual contact.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Childbearing Potential Sexual Abstinence | Natural Family Planning Methods Unacceptable | Rhythm method of contraception Unacceptable | Oral contraception Unacceptable | Temperature method of contraception Unacceptable | Withdrawal Unacceptable
Item
* true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. note: periodic abstinence (e.g, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C1256761 (UMLS CUI [2,1])
C1883420 (UMLS CUI [2,2])
C0035513 (UMLS CUI [3,1])
C1883420 (UMLS CUI [3,2])
C0029151 (UMLS CUI [4,1])
C1883420 (UMLS CUI [4,2])
C0419534 (UMLS CUI [5,1])
C1883420 (UMLS CUI [5,2])
C3812880 (UMLS CUI [6,1])
C1883420 (UMLS CUI [6,2])
Gender Sexual Abstinence | Gender Male Condoms
Item
11. male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following investigational product discontinuation, even if he has undergone a successful vasectomy.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0009653 (UMLS CUI [2,2])
Informed Consent
Item
12. subject must understand and voluntarily sign an informed consent form prior to any study related assessments or procedures being conducted.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
13. subject must be able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Study Subject Symptomatic Brain scan
Item
1. subject has current or a history of brain metastasis. in subjects who are symptomatic, a brain scan is required to exclude metastasis.
boolean
C0220650 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0596217 (UMLS CUI [2,3])
Peripheral Neuropathy CTCAE Grades | regorafenib | Therapeutic radiology procedure | Involved-Field Radiation Therapy Palliation | Therapeutic radiology procedure Bone Marrow Percentage
Item
2. subject has ≥ national cancer institute common terminology criteria for adverse events grade 2 peripheral neuropathy at screening 3. subject has had prior treatment with regorafenib 4. subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30% of the bone marrow was irradiated. radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C2980094 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C3826993 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C0005953 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
Major surgery | Recovery Lacking Postoperative Complications | Recovery Lacking Toxicity Cancer treatment | Recovery Lacking Toxicity Therapeutic radiology procedure | Recovery Lacking Toxicity Traumatic injury | Hypersensitivity Nab-paclitaxel | Hypersensitivity Nab-paclitaxel Excipient | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Heart failure New York Heart Association Classification | Uncontrolled hypertension | Cardiac Arrhythmia | Electrocardiogram abnormal | Cerebrovascular accident | Transient Ischemic Attack | Epilepsy | Hepatitis B | Hepatitis C | HIV Infection | Immunosuppressive Agents | Myelosuppressive Therapy | Bacterial Infections Uncontrolled Requirement Systemic therapy | Virus Diseases Uncontrolled Requirement Systemic therapy | Mycoses Uncontrolled Requirement Systemic therapy | Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of body of uterus Treated | Exception Skin carcinoma Treated | Connective Tissue Diseases | Lupus Erythematosus | Scleroderma | Arteritis nodosa | Lung Diseases, Interstitial | Slowly progressive Dyspnea | Dry cough | Sarcoidosis | Silicosis | Idiopathic Pulmonary Fibrosis | Hypersensitivity Pulmonary | Pneumonitis | Multiple allergies | Medical condition Severe Study Subject Participation Status Contraindicated | Medical condition Uncontrolled Study Subject Participation Status Contraindicated | Pancreatitis, Chronic | Hepatitis, Chronic | Study Subject Participation Status | Investigational New Drugs | Interference Interventional procedure | Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorders Study Subject Participation Status Excluded | Condition Interferes with Interpretation Research data | Protocol Compliance Unwilling | Protocol Compliance Unable | Pregnancy | Breast Feeding
Item
5. subject has had major surgery within 14 days prior to starting investigational product or has not recovered from postoperative complications 6. subject has not recovered from the acute toxic effects of prior anticancer therapy, radiation or major /significant trauma 7. subject has a history of allergy or hypersensitivity to nab-paclitaxel or any of the excipients 8. subject has a known history of the following within 6 months prior to enrollment (the decision to include the subject in the study): a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, new york heart association class iii-iv heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder 9. subject has a known infection with hepatitis b or c, or history of human immunodeficiency virus infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications 10. subject has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment 11. subject has any other malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment) 12. subject has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 13. subject has a history of interstitial lung disease , history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 14. subject has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate subject participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.) 15. subject is enrolled in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures 16. subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 17. subject has any condition that confounds the ability to interpret data from the study 18. subject is unwilling or unable to comply with study procedures 19. subject is a pregnant or nursing female
boolean
C0679637 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0032787 (UMLS CUI [2,3])
C2004454 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
C0920425 (UMLS CUI [3,4])
C2004454 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
C0600688 (UMLS CUI [4,3])
C1522449 (UMLS CUI [4,4])
C2004454 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C0600688 (UMLS CUI [5,3])
C3263723 (UMLS CUI [5,4])
C0020517 (UMLS CUI [6,1])
C1527223 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C1527223 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
C0027051 (UMLS CUI [8])
C0002962 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0002965 (UMLS CUI [10])
C0010055 (UMLS CUI [11])
C0190961 (UMLS CUI [12])
C0018801 (UMLS CUI [13,1])
C1275491 (UMLS CUI [13,2])
C1868885 (UMLS CUI [14])
C0003811 (UMLS CUI [15])
C0522055 (UMLS CUI [16])
C0038454 (UMLS CUI [17])
C0007787 (UMLS CUI [18])
C0014544 (UMLS CUI [19])
C0019163 (UMLS CUI [20])
C0019196 (UMLS CUI [21])
C0019693 (UMLS CUI [22])
C0021081 (UMLS CUI [23])
C1513793 (UMLS CUI [24])
C0004623 (UMLS CUI [25,1])
C0205318 (UMLS CUI [25,2])
C1514873 (UMLS CUI [25,3])
C1515119 (UMLS CUI [25,4])
C0042769 (UMLS CUI [26,1])
C0205318 (UMLS CUI [26,2])
C1514873 (UMLS CUI [26,3])
C1515119 (UMLS CUI [26,4])
C0026946 (UMLS CUI [27,1])
C0205318 (UMLS CUI [27,2])
C1514873 (UMLS CUI [27,3])
C1515119 (UMLS CUI [27,4])
C1707251 (UMLS CUI [28])
C1705847 (UMLS CUI [29,1])
C0851140 (UMLS CUI [29,2])
C1522326 (UMLS CUI [29,3])
C1705847 (UMLS CUI [30,1])
C0555282 (UMLS CUI [30,2])
C1522326 (UMLS CUI [30,3])
C1705847 (UMLS CUI [31,1])
C0699893 (UMLS CUI [31,2])
C1522326 (UMLS CUI [31,3])
C0009782 (UMLS CUI [32])
C0409974 (UMLS CUI [33])
C0011644 (UMLS CUI [34])
C1388500 (UMLS CUI [35])
C0206062 (UMLS CUI [36])
C0239202 (UMLS CUI [37,1])
C0439834 (UMLS CUI [37,2])
C0850149 (UMLS CUI [38])
C0036202 (UMLS CUI [39])
C0037116 (UMLS CUI [40])
C1800706 (UMLS CUI [41])
C0020517 (UMLS CUI [42,1])
C2709248 (UMLS CUI [42,2])
C3714636 (UMLS CUI [43])
C0740281 (UMLS CUI [44])
C3843040 (UMLS CUI [45,1])
C0205082 (UMLS CUI [45,2])
C2348568 (UMLS CUI [45,3])
C1444657 (UMLS CUI [45,4])
C3843040 (UMLS CUI [46,1])
C0205318 (UMLS CUI [46,2])
C2348568 (UMLS CUI [46,3])
C1444657 (UMLS CUI [46,4])
C0149521 (UMLS CUI [47])
C0019189 (UMLS CUI [48])
C2348568 (UMLS CUI [49])
C0013230 (UMLS CUI [50])
C0521102 (UMLS CUI [51,1])
C0184661 (UMLS CUI [51,2])
C3843040 (UMLS CUI [52,1])
C2348568 (UMLS CUI [52,2])
C0332196 (UMLS CUI [52,3])
C0438215 (UMLS CUI [53,1])
C2348568 (UMLS CUI [53,2])
C0332196 (UMLS CUI [53,3])
C0004936 (UMLS CUI [54,1])
C2348568 (UMLS CUI [54,2])
C0332196 (UMLS CUI [54,3])
C0348080 (UMLS CUI [55,1])
C0521102 (UMLS CUI [55,2])
C0459471 (UMLS CUI [55,3])
C0681873 (UMLS CUI [55,4])
C0525058 (UMLS CUI [56,1])
C0558080 (UMLS CUI [56,2])
C0525058 (UMLS CUI [57,1])
C1299582 (UMLS CUI [57,2])
C0032961 (UMLS CUI [58])
C0006147 (UMLS CUI [59])