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

Versions (1)
  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

English

Eligibility Lung Cancer NCT02321540

1 forms  
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
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Similar models

Eligibility Lung Cancer NCT02321540

1 forms
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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