ID

37103

Description

Phase 2 Study With Abraxane (Nab®Paclitaxel) in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02103062

Link

https://clinicaltrials.gov/show/NCT02103062

Keywords

  1. 3/6/19 3/6/19 -
  2. 7/3/19 7/3/19 - Sarah Riepenhausen
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Colorectal Neoplasms NCT02103062

Eligibility Colorectal Neoplasms NCT02103062

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is ≥ 18 years old at the time of signing the informed consent form
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subject has histological or cytological diagnosis of adenocarcinoma of the colon or rectum, with evidence of metastasis
Description

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Data type

boolean

Alias
UMLS CUI [1]
C4324497
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
3. subject has a known kras mutation status (mutated or wild-type). nras mutation status may be unknown.
Description

KRAS mutation | KRAS gene Wild Type | NRAS gene Mutation Unknown

Data type

boolean

Alias
UMLS CUI [1]
C2747837
UMLS CUI [2,1]
C1537502
UMLS CUI [2,2]
C1883559
UMLS CUI [3,1]
C0809246
UMLS CUI [3,2]
C0596611
UMLS CUI [3,3]
C0439673
4. subject has documented disease progression ≤ 2 months after the last administration of the last standard therapy.
Description

Disease Progression | Status post Standard therapy

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C2936643
a. subjects treated with oxaliplatin in the adjuvant setting, should have progressed during or within 6 months of completion of adjuvant therapy
Description

oxaliplatin | Adjuvant therapy | Disease Progression | Adjuvant therapy Complete

Data type

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0205197
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).
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0596581
UMLS CUI [4]
C0069717
UMLS CUI [5]
C0123931
UMLS CUI [6]
C0596087
UMLS CUI [7]
C0796392
UMLS CUI [8]
C3485619
UMLS CUI [9,1]
C0006826
UMLS CUI [9,2]
C4331207
UMLS CUI [10]
C1443775
UMLS CUI [11]
C0995188
UMLS CUI [12]
C0879427
6. subject has eastern cooperative oncology group performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
7. subject has radiographically-documented measurable disease, as per response evaluation criteria in solid tumors version 1.1 criteria
Description

Measurable Disease Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0034571
8. subject has adequate organ functions, evidenced by the following: 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
Description

Organ Function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
2. total bilirubin ≤ 1.5 × upper limit of normal range
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
3. creatinine ≤ 1.5 × upper limit of normal range
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
9. subject has adequate bone marrow function, evidenced by the following: 1. absolute neutrophil count ≥ 1.5 × 109 cells/millimeters3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
2. platelets ≥ 100 × 109 cells/millimeters3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
Description

Platelet Count measurement | Independent of Transfusion | Platelet Transfusion Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1879316
UMLS CUI [3,1]
C0086818
UMLS CUI [3,2]
C0332197
3. hemoglobin ≥ 9 grams/decilitre (transfusion is permitted to fulfill this criterion)
Description

Hemoglobin measurement | Transfusion allowed

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C1879316
UMLS CUI [2,2]
C0683607
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:
Description

Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0278321
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
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
Description

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
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.
Description

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Pregnancy Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
* 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.
Description

Childbearing Potential Sexual Abstinence | Natural Family Planning Methods Unacceptable | Rhythm method of contraception Unacceptable | Oral contraception Unacceptable | Temperature method of contraception Unacceptable | Withdrawal Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C1256761
UMLS CUI [2,2]
C1883420
UMLS CUI [3,1]
C0035513
UMLS CUI [3,2]
C1883420
UMLS CUI [4,1]
C0029151
UMLS CUI [4,2]
C1883420
UMLS CUI [5,1]
C0419534
UMLS CUI [5,2]
C1883420
UMLS CUI [6,1]
C3812880
UMLS CUI [6,2]
C1883420
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.
Description

Gender Sexual Abstinence | Gender Male Condoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0009653
12. subject must understand and voluntarily sign an informed consent form prior to any study related assessments or procedures being conducted.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
13. subject must be able to adhere to the study visit schedule and other protocol requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has current or a history of brain metastasis. in subjects who are symptomatic, a brain scan is required to exclude metastasis.
Description

Metastatic malignant neoplasm to brain | Study Subject Symptomatic Brain scan

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0596217
2. subject has ≥ national cancer institute common terminology criteria for adverse events grade 2 peripheral neuropathy at screening
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
3. subject has had prior treatment with regorafenib
Description

regorafenib

Data type

boolean

Alias
UMLS CUI [1]
C2980094
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.
Description

Therapeutic radiology procedure | Involved-Field Radiation Therapy Palliation | Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C3826993
UMLS CUI [2,2]
C0030231
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0005953
UMLS CUI [3,3]
C0439165
5. subject has had major surgery within 14 days prior to starting investigational product or has not recovered from postoperative complications
Description

Major surgery | Recovery Lacking Postoperative Complications

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0032787
6. subject has not recovered from the acute toxic effects of prior anticancer therapy, radiation or major /significant trauma
Description

Recovery Lacking Toxicity Cancer treatment | Recovery Lacking Toxicity Therapeutic radiology procedure | Recovery Lacking Toxicity Traumatic injury

Data type

boolean

Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0600688
UMLS CUI [1,4]
C0920425
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0600688
UMLS CUI [2,4]
C1522449
UMLS CUI [3,1]
C2004454
UMLS CUI [3,2]
C0332268
UMLS CUI [3,3]
C0600688
UMLS CUI [3,4]
C3263723
7. subject has a history of allergy or hypersensitivity to nab-paclitaxel or any of the excipients
Description

Hypersensitivity Nab-paclitaxel | Hypersensitivity Nab-paclitaxel Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1527223
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1527223
UMLS CUI [2,3]
C0015237
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0190961
UMLS CUI [6,1]
C0018801
UMLS CUI [6,2]
C1275491
UMLS CUI [7]
C1868885
UMLS CUI [8]
C0003811
UMLS CUI [9]
C0522055
UMLS CUI [10]
C0038454
UMLS CUI [11]
C0007787
UMLS CUI [12]
C0014544
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
Description

Hepatitis B | Hepatitis C | HIV Infection | Immunosuppressive Agents | Myelosuppressive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0021081
UMLS CUI [5]
C1513793
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
Description

Bacterial Infections Uncontrolled Requirement Systemic therapy | Virus Diseases Uncontrolled Requirement Systemic therapy | Mycoses Uncontrolled Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C1515119
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1515119
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C1515119
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)
Description

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of body of uterus Treated | Exception Skin carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0555282
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [4,3]
C1522326
12. subject has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
Description

Connective Tissue Diseases | Lupus Erythematosus | Scleroderma | Arteritis nodosa

Data type

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0011644
UMLS CUI [4]
C1388500
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
Description

Lung Diseases, Interstitial | Slowly progressive Dyspnea | Dry cough | Sarcoidosis | Silicosis | Idiopathic Pulmonary Fibrosis | Hypersensitivity Pulmonary | Pneumonitis | Multiple allergies

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2,1]
C0239202
UMLS CUI [2,2]
C0439834
UMLS CUI [3]
C0850149
UMLS CUI [4]
C0036202
UMLS CUI [5]
C0037116
UMLS CUI [6]
C1800706
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C2709248
UMLS CUI [8]
C3714636
UMLS CUI [9]
C0740281
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.)
Description

Medical condition Severe Study Subject Participation Status Contraindicated | Medical condition Uncontrolled Study Subject Participation Status Contraindicated | Pancreatitis, Chronic | Hepatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444657
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444657
UMLS CUI [3]
C0149521
UMLS CUI [4]
C0019189
15. subject is enrolled in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
Description

Study Subject Participation Status | Investigational New Drugs | Interference Interventional procedure

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0184661
16. subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Description

Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorders Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
17. subject has any condition that confounds the ability to interpret data from the study
Description

Condition Interferes with Interpretation Research data

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0681873
18. subject is unwilling or unable to comply with study procedures
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
19. subject is a pregnant or nursing female
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Colorectal Neoplasms NCT02103062

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is ≥ 18 years old at the time of signing the informed consent form
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
2. subject has histological or cytological diagnosis of adenocarcinoma of the colon or rectum, with evidence of metastasis
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
KRAS mutation | KRAS gene Wild Type | NRAS gene Mutation Unknown
Item
3. subject has a known kras mutation status (mutated or wild-type). nras mutation status may be unknown.
boolean
C2747837 (UMLS CUI [1])
C1537502 (UMLS CUI [2,1])
C1883559 (UMLS CUI [2,2])
C0809246 (UMLS CUI [3,1])
C0596611 (UMLS CUI [3,2])
C0439673 (UMLS CUI [3,3])
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
Item
a. subjects treated with oxaliplatin in the adjuvant setting, should have progressed during or within 6 months of completion of adjuvant therapy
boolean
C0069717 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C0677850 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
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
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
C1514463 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0596581 (UMLS CUI [3])
C0069717 (UMLS CUI [4])
C0123931 (UMLS CUI [5])
C0596087 (UMLS CUI [6])
C0796392 (UMLS CUI [7])
C3485619 (UMLS CUI [8])
C0006826 (UMLS CUI [9,1])
C4331207 (UMLS CUI [9,2])
C1443775 (UMLS CUI [10])
C0995188 (UMLS CUI [11])
C0879427 (UMLS CUI [12])
ECOG performance status
Item
6. subject has eastern cooperative oncology group performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Radiography
Item
7. subject has radiographically-documented measurable disease, as per response evaluation criteria in solid tumors version 1.1 criteria
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Organ Function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
8. subject has adequate organ functions, evidenced by the following: 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
C0678852 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Serum total bilirubin measurement
Item
2. total bilirubin ≤ 1.5 × upper limit of normal range
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
3. creatinine ≤ 1.5 × upper limit of normal range
boolean
C0201976 (UMLS CUI [1])
Absolute neutrophil count
Item
9. subject has adequate bone marrow function, evidenced by the following: 1. absolute neutrophil count ≥ 1.5 × 109 cells/millimeters3
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
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
Item
3. hemoglobin ≥ 9 grams/decilitre (transfusion is permitted to fulfill this criterion)
boolean
C0518015 (UMLS CUI [1])
C1879316 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent
Item
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
C3831118 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
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])
Item Group
C0680251 (UMLS CUI)
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
Item
2. subject has ≥ national cancer institute common terminology criteria for adverse events grade 2 peripheral neuropathy at screening
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
regorafenib
Item
3. subject has had prior treatment with regorafenib
boolean
C2980094 (UMLS CUI [1])
Therapeutic radiology procedure | Involved-Field Radiation Therapy Palliation | Therapeutic radiology procedure Bone Marrow Percentage
Item
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
C1522449 (UMLS CUI [1])
C3826993 (UMLS CUI [2,1])
C0030231 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
Major surgery | Recovery Lacking Postoperative Complications
Item
5. subject has had major surgery within 14 days prior to starting investigational product or has not recovered from postoperative complications
boolean
C0679637 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0032787 (UMLS CUI [2,3])
Recovery Lacking Toxicity Cancer treatment | Recovery Lacking Toxicity Therapeutic radiology procedure | Recovery Lacking Toxicity Traumatic injury
Item
6. subject has not recovered from the acute toxic effects of prior anticancer therapy, radiation or major /significant trauma
boolean
C2004454 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
C2004454 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
C3263723 (UMLS CUI [3,4])
Hypersensitivity Nab-paclitaxel | Hypersensitivity Nab-paclitaxel Excipient
Item
7. subject has a history of allergy or hypersensitivity to nab-paclitaxel or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C1527223 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1527223 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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
Item
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
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0190961 (UMLS CUI [5])
C0018801 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C1868885 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
C0522055 (UMLS CUI [9])
C0038454 (UMLS CUI [10])
C0007787 (UMLS CUI [11])
C0014544 (UMLS CUI [12])
Hepatitis B | Hepatitis C | HIV Infection | Immunosuppressive Agents | Myelosuppressive Therapy
Item
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
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C1513793 (UMLS CUI [5])
Bacterial Infections Uncontrolled Requirement Systemic therapy | Virus Diseases Uncontrolled Requirement Systemic therapy | Mycoses Uncontrolled Requirement Systemic therapy
Item
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
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1515119 (UMLS CUI [1,4])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1515119 (UMLS CUI [2,4])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C1515119 (UMLS CUI [3,4])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of body of uterus Treated | Exception Skin carcinoma Treated
Item
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)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0555282 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Connective Tissue Diseases | Lupus Erythematosus | Scleroderma | Arteritis nodosa
Item
12. subject has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
boolean
C0009782 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0011644 (UMLS CUI [3])
C1388500 (UMLS CUI [4])
Lung Diseases, Interstitial | Slowly progressive Dyspnea | Dry cough | Sarcoidosis | Silicosis | Idiopathic Pulmonary Fibrosis | Hypersensitivity Pulmonary | Pneumonitis | Multiple allergies
Item
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
boolean
C0206062 (UMLS CUI [1])
C0239202 (UMLS CUI [2,1])
C0439834 (UMLS CUI [2,2])
C0850149 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
C0037116 (UMLS CUI [5])
C1800706 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C2709248 (UMLS CUI [7,2])
C3714636 (UMLS CUI [8])
C0740281 (UMLS CUI [9])
Medical condition Severe Study Subject Participation Status Contraindicated | Medical condition Uncontrolled Study Subject Participation Status Contraindicated | Pancreatitis, Chronic | Hepatitis, Chronic
Item
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.)
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444657 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444657 (UMLS CUI [2,4])
C0149521 (UMLS CUI [3])
C0019189 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Interference Interventional procedure
Item
15. subject is enrolled in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0521102 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorders Study Subject Participation Status Excluded
Item
16. subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Condition Interferes with Interpretation Research data
Item
17. subject has any condition that confounds the ability to interpret data from the study
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
18. subject is unwilling or unable to comply with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
19. subject is a pregnant or nursing female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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