ID

36402

Description

Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02448810

Link

https://clinicaltrials.gov/show/NCT02448810

Keywords

Versions (1)
  1. 5/11/19 5/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 11, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Metastatic Colorectal Cancer NCT02448810

English

Eligibility Metastatic Colorectal Cancer NCT02448810

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of a signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. male and female subjects 18 years of age and older at the time of screening
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. subjects who progressed after receiving at least 2, but no more than 3, prior soc treatment lines
Description

Disease Progression | Status post Standard therapy Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C1265611
4. anticipated life expectancy >3 months at the time of screening
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
5. weight between 40 kg and 180 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
6. histologically or cytologically confirmed diagnosis of crc
Description

Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0009402
7. metastatic crc not amenable to surgical resection
Description

Colorectal cancer metastatic Inappropriate Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
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)
Description

KRAS gene Mutation Status Known | NRAS gene Mutation Status Known

Data type

boolean

Alias
UMLS CUI [1,1]
C1537502
UMLS CUI [1,2]
C0026882
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C0205309
UMLS CUI [2,1]
C0809246
UMLS CUI [2,2]
C0026882
UMLS CUI [2,3]
C0449438
UMLS CUI [2,4]
C0205309
9. at least 1 measurable lesion as defined by recist v1.1
Description

Measurable Disease Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
10. ecog ps of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
11. adequate hematological function, defined as:
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
1. platelet count ≥ 100,000/μl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
2. prothrombin time and activated partial thromboplastin time (aptt) < 1.5 times the upper limit of normal (uln)
Description

Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
3. absolute neutrophil count (anc) ≥ 1,000/μl
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
4. hemoglobin ≥ 9 g/dl, without the need for transfusion in the 2 weeks prior to screening
Description

Hemoglobin measurement | Requirement Absent Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0005841
12. adequate renal function, defined as serum creatinine ≤ 2.0 times uln and creatinine clearance > 50 ml/min
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
13. adequate liver function, defined as:
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
1. aspartate aminotransferase (ast) and alanine aminotransferase (alt)
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
≤ 2.5 times uln for subjects without liver metastases, or ≤ 5 times uln in the presence of liver metastases
Description

Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0494165
2. bilirubin ≤ 2.0 times uln, unless subject has known gilbert's syndrome
Description

Serum total bilirubin measurement | Exception Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
14. adequate venous access
Description

Venous access patent

Data type

boolean

Alias
UMLS CUI [1]
C3164222
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0042241
UMLS CUI [5]
C3843423
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0682323
UMLS CUI [6,3]
C0009653
UMLS CUI [7]
C0009905
UMLS CUI [8]
C2985284
UMLS CUI [9]
C0021900
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0009653
UMLS CUI [4]
C3843423
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0042241
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C3843423
UMLS CUI [7,1]
C0682323
UMLS CUI [7,2]
C0009905
UMLS CUI [8,1]
C0682323
UMLS CUI [8,2]
C2985284
UMLS CUI [9,1]
C0682323
UMLS CUI [9,2]
C0021900
UMLS CUI [10,1]
C0079399
UMLS CUI [10,2]
C0871414
UMLS CUI [10,3]
C0332197
17. subject is willing and able to comply with the requirements of the protocol.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known central nervous system metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C0205179
UMLS CUI [4,4]
C1517927
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007124
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1336527
3. prior treatment with panitumumab for subjects with kras and nras wt tumor
Description

panitumumab | Neoplasm KRAS gene Wild Type | Neoplasm NRAS gene Wild Type

Data type

boolean

Alias
UMLS CUI [1]
C0879427
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1537502
UMLS CUI [2,3]
C1883559
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0809246
UMLS CUI [3,3]
C1883559
4. residual ae from previous treatment > grade 1
Description

Prior Therapy | Adverse event Residual CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1609982
UMLS CUI [2,3]
C1516728
5. prior intolerance to fluoropyrimidine for subjects with kras or nras mut tumor
Description

Intolerance to Fluoropyrimidine | Neoplasm KRAS Gene Mutation | Neoplasm NRAS gene mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0596581
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1517649
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1513808
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1514873
UMLS CUI [6,1]
C1444641
UMLS CUI [6,2]
C0344432
UMLS CUI [7]
C0020621
UMLS CUI [8]
C3839836
7. uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmhg and/or diastolic blood pressure ≥ 100 mmhg confirmed upon repeated measures
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
8. lvef < 40% as determined by echocardiogram performed at screening or within 90 days prior to c1d1
Description

Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
9. qt/qtc interval > 450 msec, as determined by screening ecg performed no earlier than 1 week before c1d1
Description

ECG QT interval | ECG QTc interval

Data type

boolean

Alias
UMLS CUI [1]
C0429028
UMLS CUI [2]
C2216079
10. prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within 4 weeks prior to c1d1.
Description

Cancer treatment | Chemotherapy | Therapeutic radiology procedure | Antibody therapy | Molecular Targeted Therapy | Retinoid therapy of cancer | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0281176
UMLS CUI [5]
C2699893
UMLS CUI [6]
C0598926
UMLS CUI [7]
C0279025
11. major surgery within 4 weeks prior to c1d1
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
12. active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
Description

Inflamed joint | Arthritis | Immune System Diseases Involving Joints

Data type

boolean

Alias
UMLS CUI [1]
C0574941
UMLS CUI [2]
C0003864
UMLS CUI [3,1]
C0021053
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0022417
13. active infection involving iv antibiotics within 2 weeks prior to c1d1
Description

Communicable Disease Involving Antibiotics Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C1522726
14. known history of, or active hepatitis b virus (hbv), hepatitis c virus (hcv) or active tuberculosis
Description

Hepatitis B | Hepatitis C | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0041296
15. known history of human immunodeficiency virus (hiv) type 1/2 or other immunodeficiency disease
Description

HIV-1 infection | HIV-2 infection | Immunodeficiency disease

Data type

boolean

Alias
UMLS CUI [1]
C2363741
UMLS CUI [2]
C0854094
UMLS CUI [3]
C0021051
16. subject has received a live vaccine within 4 weeks prior to c1d1
Description

Vaccines, Attenuated

Data type

boolean

Alias
UMLS CUI [1]
C0042211
17. known hypersensitivity to any component of recombinant protein production by cho cells
Description

Hypersensitivity Recombinant Proteins CHO Cells

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0034861
UMLS CUI [1,3]
C0085080
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
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Scheduled | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0205539
UMLS CUI [5]
C0013230
UMLS CUI [6]
C2346570
19. subject is nursing or intends to begin nursing during the course of the study
Description

Breast Feeding | Breast Feeding intended

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1283828
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0854146
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0522055
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0681850
UMLS CUI [6,1]
C0438215
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0681850
UMLS CUI [7,1]
C0854146
UMLS CUI [7,2]
C1444641
UMLS CUI [7,3]
C0681850
UMLS CUI [8,1]
C0522055
UMLS CUI [8,2]
C1444641
UMLS CUI [8,3]
C0681850
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0683954
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0683954
UMLS CUI [11,1]
C0854146
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0683954
UMLS CUI [12,1]
C0522055
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0683954
21. subject is a family member or employee of the investigator
Description

Study Subject Family member Investigator | Study Subject Employee Investigator

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0086282
UMLS CUI [1,3]
C0035173
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0599987
UMLS CUI [2,3]
C0035173
Back to the top of the page

Similar models

Eligibility Metastatic Colorectal Cancer NCT02448810

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial