ID

38517

Description

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01647711

Link

https://clinicaltrials.gov/show/NCT01647711

Keywords

Versions (1)
  1. 10/23/19 10/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01647711

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT01647711

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
part a only:
Description

Part Roman letter

Data type

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0439102
1. patients with histologically confirmed advanced solid tumours that are metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. patients who refuse standard therapy are also eligible.
Description

Advanced Malignant Solid Neoplasm metastatic | Advanced Malignant Solid Neoplasm unresectable | Standard Curative treatment Unavailable | Standard Palliative Care Unavailable | Standard Curative treatment ineffective | Standard Palliative Care ineffective | Standard therapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C4329281
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C4329281
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C1442989
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0686905
UMLS CUI [4,1]
C1442989
UMLS CUI [4,2]
C0030231
UMLS CUI [4,3]
C0686905
UMLS CUI [5,1]
C1442989
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C3242229
UMLS CUI [6,1]
C1442989
UMLS CUI [6,2]
C0030231
UMLS CUI [6,3]
C3242229
UMLS CUI [7,1]
C2936643
UMLS CUI [7,2]
C1705116
part b only:
Description

Part Roman letter

Data type

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0439102
2. pathologically confirmed diagnosis of stage iv (m1a or b) non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
3. documented epidermal growth factor receptor (egfr) t790m mutation
Description

EGFR T790M Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C3274192
UMLS CUI [1,2]
C0026882
4. progression of disease on a reversible tyrosine kinase inhibitor within 30 days of starting study drug
Description

Disease Progression | Tyrosine kinase inhibitor Reversible

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1268567
UMLS CUI [2,2]
C0205343
parts a and b:
Description

Part Roman letter

Data type

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0439102
5. evaluable disease by response evaluation criteria in solid tumors (recist) version 1.1
Description

Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1516986
6. age >/= to 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
7. eastern cooperative group (ecog) performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
9. recovered from any previous therapy-related toxicity to </= to grade 1 at study entry (except for stable sensory neuropathy </= grade 2 and alopecia)
Description

Toxicity Prior Therapy Related | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0439849
UMLS CUI [2]
C1115804
10. written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
11. ability to take oral medication
Description

Able to swallow Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
parts a and b:
Description

Part Roman letter

Data type

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0439102
1. chemotherapy, biological therapy, or investigational agents (except erlotinib or gefitinib) within 4 weeks prior to the start of study treatment
Description

Chemotherapy | Biological treatment | Investigational New Drugs | Exception Erlotinib | Exception Gefitinib

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1135135
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1122962
2. hormonal treatment within 2 weeks prior to the start of study treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer is permitted)
Description

Hormone Therapy | Antiandrogen therapy allowed Prostate carcinoma | Gonadorelin Analogue allowed Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0683607
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C0023610
UMLS CUI [3,2]
C0243071
UMLS CUI [3,3]
C0683607
UMLS CUI [3,4]
C0600139
3. radiotherapy within two weeks prior to the start of study treatment (except palliative radiotherapy given for symptom control)
Description

Therapeutic radiology procedure | Exception Palliative Radiation Therapy Symptom control

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3898008
UMLS CUI [2,3]
C1274136
4. less than 3 days from prior treatment with gefitinib or erlotinib. patients with adverse events related to gefitinib or erlotinib must recover to grade 1 or less to be eligible.
Description

Gefitinib Recent | Erlotinib Recent | Adverse event Gefitinib Related | Adverse event Erlotinib Related | Patient recovered CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C1122962
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1135135
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C1122962
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C1135135
UMLS CUI [4,3]
C0439849
UMLS CUI [5,1]
C1115804
UMLS CUI [5,2]
C1516728
5. major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
Description

Major surgery | Major surgery Scheduled

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0205539
6. known hypersensitivity to afatinib or the excipients of any of the trial drugs
Description

Hypersensitivity Afatinib | Hypersensitivity Investigational New Drug Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2987648
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
7. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure new york heart association classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. myocardial infarction within 6 months prior to starting study treatment
Description

Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0243050
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C3853134
UMLS CUI [6]
C0027051
8. women of childbearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
Description

Females & males of reproductive potential Sexual Abstinence Unwilling | Females & males of reproductive potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
9. female patients of childbearing potential who are nursing; are pregnant; are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study; and do not agree to submit to pregnancy testing required by this protocol
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
UMLS CUI [4,3]
C0558080
10. any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Description

Medical History compromises Protocol Compliance | Condition compromises Protocol Compliance | Medical History Interferes with Evaluation | Condition Interferes with Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0220825
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0220825
11. previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
Description

Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007124
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C1880198
12. required treatment with any of the prohibited medications listed in this protocol that cannot be stopped for the duration of trial participation
Description

llicit medication use Required | Illicit medication use Discontinue Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0281875
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1272705
13. known pre-existing interstitial lung disease
Description

Interstitial Lung Disease Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
14. any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (for example, crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption) in the opinion of the investigator
Description

Gastrointestinal Diseases Poorly controlled | Involvement with Absorption Investigational New Drugs | Crohn Disease | Ulcerative Colitis | Chronic diarrhea | Malabsorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0013230
UMLS CUI [3]
C0010346
UMLS CUI [4]
C0009324
UMLS CUI [5]
C0401151
UMLS CUI [6]
C3714745
15. active hepatitis b infection (defined as the presence of hepatitis b dna), active hepatitis c infection (defined as the presence of hepatitis c rna) and/or known human immunodeficiency virus carrier
Description

Hepatitis B | Hepatitis B DNA detectable | Hepatitis C | Hepatitis C RNA Present | Human immunodeficiency virus carrier

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C1096264
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0855840
UMLS CUI [4,2]
C0150312
UMLS CUI [5]
C0421166
16. prior participation in a blinded afatinib clinical study, unless permission to unblind was granted in consultation with the clinical monitor of the blinded study
Description

Study Subject Participation Status | Blinded Clinical Study Afatinib

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2347038
UMLS CUI [2,2]
C2987648
17. meningeal carcinomatosis
Description

Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
18. patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued use of corticosteroids or have been on stable doses of corticosteroids for at least 4 weeks before starting study treatment. any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment
Description

Metastatic malignant neoplasm to brain | Neoplasm Metastasis Subdural | Exception Local Therapy Completed | Exception Adrenal Cortex Hormones Discontinued | Exception Adrenal Cortex Hormones Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0038541
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1517925
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0001617
UMLS CUI [4,3]
C1444662
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0001617
UMLS CUI [5,3]
C0178602
UMLS CUI [5,4]
C0205360
19. qtc interval > 0.47 seconds as measured during screening procedures
Description

QTc Interval Screening procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0860814
UMLS CUI [1,2]
C0220908
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01647711

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Part Roman letter
Item
part a only:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Advanced Malignant Solid Neoplasm metastatic | Advanced Malignant Solid Neoplasm unresectable | Standard Curative treatment Unavailable | Standard Palliative Care Unavailable | Standard Curative treatment ineffective | Standard Palliative Care ineffective | Standard therapy Refused
Item
1. patients with histologically confirmed advanced solid tumours that are metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. patients who refuse standard therapy are also eligible.
boolean
C4329281 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C4329281 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1442989 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0686905 (UMLS CUI [3,3])
C1442989 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0686905 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C3242229 (UMLS CUI [5,3])
C1442989 (UMLS CUI [6,1])
C0030231 (UMLS CUI [6,2])
C3242229 (UMLS CUI [6,3])
C2936643 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Part Roman letter
Item
part b only:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
2. pathologically confirmed diagnosis of stage iv (m1a or b) non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
EGFR T790M Mutation
Item
3. documented epidermal growth factor receptor (egfr) t790m mutation
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
Disease Progression | Tyrosine kinase inhibitor Reversible
Item
4. progression of disease on a reversible tyrosine kinase inhibitor within 30 days of starting study drug
boolean
C0242656 (UMLS CUI [1])
C1268567 (UMLS CUI [2,1])
C0205343 (UMLS CUI [2,2])
Part Roman letter
Item
parts a and b:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Evaluable Disease
Item
5. evaluable disease by response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1516986 (UMLS CUI [1])
Age
Item
6. age >/= to 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
8. adequate organ function
boolean
C0678852 (UMLS CUI [1])
Toxicity Prior Therapy Related | Patient recovered
Item
9. recovered from any previous therapy-related toxicity to </= to grade 1 at study entry (except for stable sensory neuropathy </= grade 2 and alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Informed Consent
Item
10. written informed consent
boolean
C0021430 (UMLS CUI [1])
Able to swallow Oral medication
Item
11. ability to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Part Roman letter
Item
parts a and b:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Chemotherapy | Biological treatment | Investigational New Drugs | Exception Erlotinib | Exception Gefitinib
Item
1. chemotherapy, biological therapy, or investigational agents (except erlotinib or gefitinib) within 4 weeks prior to the start of study treatment
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1135135 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1122962 (UMLS CUI [5,2])
Hormone Therapy | Antiandrogen therapy allowed Prostate carcinoma | Gonadorelin Analogue allowed Prostate carcinoma
Item
2. hormonal treatment within 2 weeks prior to the start of study treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer is permitted)
boolean
C0279025 (UMLS CUI [1])
C0279492 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C0023610 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0600139 (UMLS CUI [3,4])
Therapeutic radiology procedure | Exception Palliative Radiation Therapy Symptom control
Item
3. radiotherapy within two weeks prior to the start of study treatment (except palliative radiotherapy given for symptom control)
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3898008 (UMLS CUI [2,2])
C1274136 (UMLS CUI [2,3])
Gefitinib Recent | Erlotinib Recent | Adverse event Gefitinib Related | Adverse event Erlotinib Related | Patient recovered CTCAE Grades
Item
4. less than 3 days from prior treatment with gefitinib or erlotinib. patients with adverse events related to gefitinib or erlotinib must recover to grade 1 or less to be eligible.
boolean
C1122962 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1135135 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C1122962 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0877248 (UMLS CUI [4,1])
C1135135 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Major surgery | Major surgery Scheduled
Item
5. major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Hypersensitivity Afatinib | Hypersensitivity Investigational New Drug Excipient
Item
6. known hypersensitivity to afatinib or the excipients of any of the trial drugs
boolean
C0020517 (UMLS CUI [1,1])
C2987648 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction
Item
7. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure new york heart association classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. myocardial infarction within 6 months prior to starting study treatment
boolean
C0243050 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
Females & males of reproductive potential Sexual Abstinence Unwilling | Females & males of reproductive potential Contraceptive methods Unwilling
Item
8. women of childbearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
boolean
C4034483 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling
Item
9. female patients of childbearing potential who are nursing; are pregnant; are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study; and do not agree to submit to pregnancy testing required by this protocol
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Medical History compromises Protocol Compliance | Condition compromises Protocol Compliance | Medical History Interferes with Evaluation | Condition Interferes with Evaluation
Item
10. any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
boolean
C0262926 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0220825 (UMLS CUI [4,3])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured
Item
11. previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
llicit medication use Required | Illicit medication use Discontinue Unsuccessful
Item
12. required treatment with any of the prohibited medications listed in this protocol that cannot be stopped for the duration of trial participation
boolean
C0281875 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0281875 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Interstitial Lung Disease Pre-existing
Item
13. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Gastrointestinal Diseases Poorly controlled | Involvement with Absorption Investigational New Drugs | Crohn Disease | Ulcerative Colitis | Chronic diarrhea | Malabsorption
Item
14. any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (for example, crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption) in the opinion of the investigator
boolean
C0017178 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0010346 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
C0401151 (UMLS CUI [5])
C3714745 (UMLS CUI [6])
Hepatitis B | Hepatitis B DNA detectable | Hepatitis C | Hepatitis C RNA Present | Human immunodeficiency virus carrier
Item
15. active hepatitis b infection (defined as the presence of hepatitis b dna), active hepatitis c infection (defined as the presence of hepatitis c rna) and/or known human immunodeficiency virus carrier
boolean
C0019163 (UMLS CUI [1])
C1096264 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0855840 (UMLS CUI [4,1])
C0150312 (UMLS CUI [4,2])
C0421166 (UMLS CUI [5])
Study Subject Participation Status | Blinded Clinical Study Afatinib
Item
16. prior participation in a blinded afatinib clinical study, unless permission to unblind was granted in consultation with the clinical monitor of the blinded study
boolean
C2348568 (UMLS CUI [1])
C2347038 (UMLS CUI [2,1])
C2987648 (UMLS CUI [2,2])
Meningeal Carcinomatosis
Item
17. meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Neoplasm Metastasis Subdural | Exception Local Therapy Completed | Exception Adrenal Cortex Hormones Discontinued | Exception Adrenal Cortex Hormones Dose Stable
Item
18. patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued use of corticosteroids or have been on stable doses of corticosteroids for at least 4 weeks before starting study treatment. any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment
boolean
C0220650 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0038541 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1517925 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0001617 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
QTc Interval Screening procedure
Item
19. qtc interval > 0.47 seconds as measured during screening procedures
boolean
C0860814 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
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