0 Ratings

ID

15389

Description

A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02321540

Link

https://clinicaltrials.gov/show/NCT02321540

Keywords

  1. 5/29/16 5/29/16 -
Uploaded on

May 29, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Lung Cancer NCT02321540

    Eligibility Lung Cancer NCT02321540

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients must have histologically or cytologically confirmed stage iv non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
    Description

    Non-small cell lung cancer metastatic | Non-small cell lung cancer recurrent Curative treatment failed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278987
    UMLS CUI [2,1]
    C0278517
    UMLS CUI [2,2]
    C1273390
    UMLS CUI [2,3]
    C0231175
    2. patients must have measurable disease by response evaluation criteria in solid tumors(recist) 1.1 criteria
    Description

    Measurable Disease Response Evaluation Criteria in Solid Tumors

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1709926
    3. documented egfr mutation by clinical laboratory improvement amendments (clia)-certified test
    Description

    EGFR gene mutation | Clinical Laboratory Improvement Act Test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3266992
    UMLS CUI [2,1]
    C2827061
    UMLS CUI [2,2]
    C0039593
    4. documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other egfr-targeted tyrosine kinase inhibitor
    Description

    Disease Progression | Therapeutic procedure | erlotinib | gefitinib | Afatinib | Epidermal growth factor receptor inhibitor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242656
    UMLS CUI [2]
    C0087111
    UMLS CUI [3]
    C1135135
    UMLS CUI [4]
    C1122962
    UMLS CUI [5]
    C2987648
    UMLS CUI [6]
    C1443775
    5. there must be tissue available from a biopsy or surgical procedure performed after progression on an egfr targeted tyrosine kinase inhibitor. if tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy
    Description

    Body tissue Availability of | Biopsy | Operative Surgical Procedures

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0040300
    UMLS CUI [1,2]
    C0470187
    UMLS CUI [2]
    C0005558
    UMLS CUI [3]
    C0543467
    6. age >/=18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    7. eastern cooperative oncology group (ecog) performance status </=2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    8. ability to take pills by mouth
    Description

    Able to swallow Pills

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2712086
    UMLS CUI [1,2]
    C0994475
    9. patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcl; absolute neutrophil count >/= 1,500/mcl; hemoglobin >/= 9 g/dl; total bilirubin </= 1.5 x institutional upper limit of normal (uln); ast(sgot)/alt(sgpt) </= 2.5 × uln or </= 5 x uln if metastases to the liver; creatinine clearance >/= 45 ml/min
    Description

    organ function | Bone Marrow physiological aspects | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Bilirubin, total measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2,1]
    C0005953
    UMLS CUI [2,2]
    C0031843
    UMLS CUI [3]
    C0023508
    UMLS CUI [4]
    C0948762
    UMLS CUI [5]
    C0019046
    UMLS CUI [6]
    C0201913
    10. patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. maximum daily dose of steroids should be prednisone 20 mg or equivalent. radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
    Description

    Metastatic malignant neoplasm to brain Asymptomatic | Anticonvulsants | Steroids | Prednisone | Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650
    UMLS CUI [1,2]
    C0231221
    UMLS CUI [2]
    C0003286
    UMLS CUI [3]
    C0038317
    UMLS CUI [4]
    C0032952
    UMLS CUI [5]
    C1522449
    11. the effects of ibrutinib on the developing human fetus are unknown. women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of ibrutinib. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of ibrutinib administration.
    Description

    Ibrutinib | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy | Males Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3501358
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [3]
    C2985296
    UMLS CUI [4]
    C0004764
    UMLS CUI [5]
    C0036899
    UMLS CUI [6]
    C0032961
    UMLS CUI [7,1]
    C0086582
    UMLS CUI [7,2]
    C0700589
    12. ability to understand and the willingness to sign a written informed consent document
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients who have received egfr tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
    Description

    Epidermal growth factor receptor inhibitor | Pharmaceutical Preparations Against Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1443775
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0521124
    UMLS CUI [2,3]
    C0006826
    2. prior treatment with ibrutinib
    Description

    Prior Therapy Ibrutinib

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C3501358
    3. known hypersensitivity to ibrutinib
    Description

    Hypersensitivity Ibrutinib

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C3501358
    4. concurrent use of agents that strongly inhibit or induce cyp3a unless use is approved by the medical monitor
    Description

    Cytochrome P-450 CYP3A Inducers Use Concurrent | Cytochrome P-450 CYP3A Inhibitors Use Concurrent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3850044
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0205420
    UMLS CUI [2,1]
    C3850056
    UMLS CUI [2,2]
    C1524063
    UMLS CUI [2,3]
    C0205420
    5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    Description

    Comorbidity Compliance behavior Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders | Social situation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C1321605
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [2]
    C0009450
    UMLS CUI [3]
    C0742758
    UMLS CUI [4]
    C0002965
    UMLS CUI [5]
    C0003811
    UMLS CUI [6]
    C0004936
    UMLS CUI [7]
    C0748872
    6. pregnant and nursing women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    7. patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
    Description

    Malignant Neoplasms Other | Malignant neoplasm of skin | Carcinoma in situ of uterine cervix | Noninfiltrating Intraductal Carcinoma | Curative treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0007114
    UMLS CUI [3]
    C0851140
    UMLS CUI [4]
    C0007124
    UMLS CUI [5]
    C1273390
    8. any gastrointestinal disorder expected to limit absorption of ibrutinib
    Description

    Gastrointestinal Disease Limiting Intestinal Absorption Ibrutinib

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0017178
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0021826
    UMLS CUI [1,4]
    C3501358
    9. treatment with warfarin or other vitamin k antagonist. patients with using warfarin who switch to another form of anticoagulation will be eligible
    Description

    Therapeutic procedure Warfarin | Treatment with Vitamin K antagonist

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0043031
    UMLS CUI [2]
    C1096489
    10. patients with persistent and uncontrolled atrial fibrillation.
    Description

    Persistent atrial fibrillation Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2585653
    UMLS CUI [1,2]
    C0205318

    Similar models

    Eligibility Lung Cancer NCT02321540

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-small cell lung cancer metastatic | Non-small cell lung cancer recurrent Curative treatment failed
    Item
    1. patients must have histologically or cytologically confirmed stage iv non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
    boolean
    C0278987 (UMLS CUI [1])
    C0278517 (UMLS CUI [2,1])
    C1273390 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    Measurable Disease Response Evaluation Criteria in Solid Tumors
    Item
    2. patients must have measurable disease by response evaluation criteria in solid tumors(recist) 1.1 criteria
    boolean
    C1513041 (UMLS CUI [1,1])
    C1709926 (UMLS CUI [1,2])
    EGFR gene mutation | Clinical Laboratory Improvement Act Test
    Item
    3. documented egfr mutation by clinical laboratory improvement amendments (clia)-certified test
    boolean
    C3266992 (UMLS CUI [1])
    C2827061 (UMLS CUI [2,1])
    C0039593 (UMLS CUI [2,2])
    Disease Progression | Therapeutic procedure | erlotinib | gefitinib | Afatinib | Epidermal growth factor receptor inhibitor
    Item
    4. documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other egfr-targeted tyrosine kinase inhibitor
    boolean
    C0242656 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    C1135135 (UMLS CUI [3])
    C1122962 (UMLS CUI [4])
    C2987648 (UMLS CUI [5])
    C1443775 (UMLS CUI [6])
    Body tissue Availability of | Biopsy | Operative Surgical Procedures
    Item
    5. there must be tissue available from a biopsy or surgical procedure performed after progression on an egfr targeted tyrosine kinase inhibitor. if tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy
    boolean
    C0040300 (UMLS CUI [1,1])
    C0470187 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2])
    C0543467 (UMLS CUI [3])
    Age
    Item
    6. age >/=18 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    7. eastern cooperative oncology group (ecog) performance status </=2
    boolean
    C1520224 (UMLS CUI [1])
    Able to swallow Pills
    Item
    8. ability to take pills by mouth
    boolean
    C2712086 (UMLS CUI [1,1])
    C0994475 (UMLS CUI [1,2])
    organ function | Bone Marrow physiological aspects | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Bilirubin, total measurement
    Item
    9. patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcl; absolute neutrophil count >/= 1,500/mcl; hemoglobin >/= 9 g/dl; total bilirubin </= 1.5 x institutional upper limit of normal (uln); ast(sgot)/alt(sgpt) </= 2.5 × uln or </= 5 x uln if metastases to the liver; creatinine clearance >/= 45 ml/min
    boolean
    C0678852 (UMLS CUI [1])
    C0005953 (UMLS CUI [2,1])
    C0031843 (UMLS CUI [2,2])
    C0023508 (UMLS CUI [3])
    C0948762 (UMLS CUI [4])
    C0019046 (UMLS CUI [5])
    C0201913 (UMLS CUI [6])
    Metastatic malignant neoplasm to brain Asymptomatic | Anticonvulsants | Steroids | Prednisone | Therapeutic radiology procedure
    Item
    10. patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. maximum daily dose of steroids should be prednisone 20 mg or equivalent. radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
    boolean
    C0220650 (UMLS CUI [1,1])
    C0231221 (UMLS CUI [1,2])
    C0003286 (UMLS CUI [2])
    C0038317 (UMLS CUI [3])
    C0032952 (UMLS CUI [4])
    C1522449 (UMLS CUI [5])
    Ibrutinib | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy | Males Contraceptive methods
    Item
    11. the effects of ibrutinib on the developing human fetus are unknown. women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of ibrutinib. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of ibrutinib administration.
    boolean
    C3501358 (UMLS CUI [1])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C2985296 (UMLS CUI [3])
    C0004764 (UMLS CUI [4])
    C0036899 (UMLS CUI [5])
    C0032961 (UMLS CUI [6])
    C0086582 (UMLS CUI [7,1])
    C0700589 (UMLS CUI [7,2])
    Informed consent
    Item
    12. ability to understand and the willingness to sign a written informed consent document
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Epidermal growth factor receptor inhibitor | Pharmaceutical Preparations Against Malignant Neoplasms
    Item
    1. patients who have received egfr tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
    boolean
    C1443775 (UMLS CUI [1])
    C0013227 (UMLS CUI [2,1])
    C0521124 (UMLS CUI [2,2])
    C0006826 (UMLS CUI [2,3])
    Prior Therapy Ibrutinib
    Item
    2. prior treatment with ibrutinib
    boolean
    C1514463 (UMLS CUI [1,1])
    C3501358 (UMLS CUI [1,2])
    Hypersensitivity Ibrutinib
    Item
    3. known hypersensitivity to ibrutinib
    boolean
    C0020517 (UMLS CUI [1,1])
    C3501358 (UMLS CUI [1,2])
    Cytochrome P-450 CYP3A Inducers Use Concurrent | Cytochrome P-450 CYP3A Inhibitors Use Concurrent
    Item
    4. concurrent use of agents that strongly inhibit or induce cyp3a unless use is approved by the medical monitor
    boolean
    C3850044 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0205420 (UMLS CUI [1,3])
    C3850056 (UMLS CUI [2,1])
    C1524063 (UMLS CUI [2,2])
    C0205420 (UMLS CUI [2,3])
    Comorbidity Compliance behavior Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders | Social situation
    Item
    5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    boolean
    C0009488 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C0009450 (UMLS CUI [2])
    C0742758 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0003811 (UMLS CUI [5])
    C0004936 (UMLS CUI [6])
    C0748872 (UMLS CUI [7])
    Pregnancy | Breast Feeding
    Item
    6. pregnant and nursing women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Malignant Neoplasms Other | Malignant neoplasm of skin | Carcinoma in situ of uterine cervix | Noninfiltrating Intraductal Carcinoma | Curative treatment
    Item
    7. patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0007114 (UMLS CUI [2])
    C0851140 (UMLS CUI [3])
    C0007124 (UMLS CUI [4])
    C1273390 (UMLS CUI [5])
    Gastrointestinal Disease Limiting Intestinal Absorption Ibrutinib
    Item
    8. any gastrointestinal disorder expected to limit absorption of ibrutinib
    boolean
    C0017178 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0021826 (UMLS CUI [1,3])
    C3501358 (UMLS CUI [1,4])
    Therapeutic procedure Warfarin | Treatment with Vitamin K antagonist
    Item
    9. treatment with warfarin or other vitamin k antagonist. patients with using warfarin who switch to another form of anticoagulation will be eligible
    boolean
    C0087111 (UMLS CUI [1,1])
    C0043031 (UMLS CUI [1,2])
    C1096489 (UMLS CUI [2])
    Persistent atrial fibrillation Uncontrolled
    Item
    10. patients with persistent and uncontrolled atrial fibrillation.
    boolean
    C2585653 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])

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