ID

38079

Descripción

Safety and Efficacy of BKM120 and Lapatinib in HER2+/PI3K-activated, Trastuzumab-resistant Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01589861

Link

https://clinicaltrials.gov/show/NCT01589861

Palabras clave

Versiones (1)
  1. 16/9/19 16/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de septiembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01589861

Inglés

Eligibility Breast Cancer NCT01589861

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female or male ≥ 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. who performance status ≤ 1
Descripción

WHO performance status scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
3. locally advanced, recurrent or metastatic, histologically confirmed her2 positive (ihc 3+ or fish positive) breast cancer after failure of trastuzumab treatment.
Descripción

Locally advanced breast cancer HER2 Positive | Breast cancer recurrent HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive | Immunohistochemistry | FISH Positive | Trastuzumab failed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C2348909
UMLS CUI [3,1]
C0346993
UMLS CUI [3,2]
C2348909
UMLS CUI [4]
C0021044
UMLS CUI [5,1]
C0162789
UMLS CUI [5,2]
C1514241
UMLS CUI [6,1]
C0728747
UMLS CUI [6,2]
C0231175
while on trastuzumab or within 4 weeks since the last infusion of trastuzumab for metastatic disease within 12 months of the last infusion for patients who received trastuzumab as adjuvant or neoadjuvant treatment
Descripción

Trastuzumab Adjuvant therapy Neoplasm Metastasis | Trastuzumab Neoadjuvant Therapy Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0677850
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C0027627
4. for the phase ii part, progression on trastuzumab must have occurred within 16 weeks before entering this trial.
Descripción

Disease Progression | trastuzumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0728747
5. should not have received more than 3 lines of anti-her2 therapy.
Descripción

Targeted Therapy Quantity HER2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0069515
6. for the phase ii part, activation of pi3k/akt pathway
Descripción

Activation PI3K/AKT1 Signaling Pathway

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1879547
UMLS CUI [1,2]
C2984369
7. capable of understanding the protocol and has signed the informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
8. laboratory values within normal range
Descripción

Normal Laboratory Test Result

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438214
9. measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
10. patients may have received treatment for brain metastases, but must be neurologically stable
Descripción

Therapeutic procedure Metastatic malignant neoplasm to brain | Stable status Neurologic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0220650
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205494
11. baseline lvef>50% (muga or echo)
Descripción

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
12. affiliation to social security
Descripción

Affiliation Social Security Program

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0037435
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment with lapatinib, neratinib or a pi3k inhibitor
Descripción

Prior Therapy | lapatinib | neratinib | PI3K Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1506770
UMLS CUI [3]
C2713008
UMLS CUI [4]
C1519050
2. untreated brain metastases.
Descripción

Metastatic malignant neoplasm to brain Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
3. acute or chronic liver, renal disease or pancreatitis
Descripción

Liver disease | Kidney Disease | Pancreatitis | Chronic liver disease | Chronic Kidney Disease | Pancreatitis, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0030305
UMLS CUI [4]
C0341439
UMLS CUI [5]
C1561643
UMLS CUI [6]
C0149521
4. any peripheral neuropathy ≥ ctcae grade 2
Descripción

Peripheral Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
5. any of the following mood disorders, or meets the cut-off score of ≥ 10 in the phq-9 or a cut-off of ≥ 15 in the gad-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the phq-9 (independent of the total score of the phq-9)
Descripción

Mood Disorders | PHQ-9 | GAD-7 | Feeling suicidal PHQ-9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525045
UMLS CUI [2]
C4083201
UMLS CUI [3]
C3641330
UMLS CUI [4,1]
C0424000
UMLS CUI [4,2]
C4083201
medically documented history of or active major depressive episode, bipolar disorder (i or ii), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
Descripción

Major depressive episode | Bipolar I disorder | Bipolar II disorder | Obsessive-Compulsive Disorder | Schizophrenia | Suicide attempt | Feeling suicidal | Homicidal thoughts | Risk of violence or harm to others

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0853193
UMLS CUI [3]
C0236788
UMLS CUI [4]
C0028768
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0038663
UMLS CUI [7]
C0424000
UMLS CUI [8]
C0455204
UMLS CUI [9]
C0549013
≥ ctcae grade 3 anxiety
Descripción

Anxiety CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003467
UMLS CUI [1,2]
C1516728
6. diarrhea ≥ ctcae grade 2
Descripción

Diarrhea CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C1516728
7. active cardiac disease
Descripción

Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
8. history of cardiac dysfunction
Descripción

Cardiac dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3277906
9. poorly controlled diabetes mellitus (hba1c > 8 %)
Descripción

Poorly controlled diabetes mellitus | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
10. other severe and/or uncontrolled concomitant medical conditions
Descripción

Comorbidity Severe | Comorbidity Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
11. impairment of gastrointestinal function that may significantly alter the absorption of bkm120
Descripción

Abnormal digestive tract function Changing Absorption BKM120

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232459
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C3491291
12. been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
Descripción

Colony-Stimulating Factors Hematopoietic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009392
UMLS CUI [1,2]
C0229601
13. currently receiving treatment with medication with a known risk prolong the qt interval or inducing torsades de pointes
Descripción

Pharmacotherapy At risk Prolonged QT interval | Pharmacotherapy Inducing Torsades de Pointes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C0040479
14. currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme cyp3a
Descripción

CYP3A Inhibitors Moderate | CYP3A Inducers Moderate | CYP3A Inhibitors Strong | CYP3A Inducers Strong

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C3850044
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C3850056
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3850044
UMLS CUI [4,2]
C0442821
15. receiving chronic treatment with steroids or another immunosuppressive agent.
Descripción

Steroids chronic | Immunosuppressive Agents chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
16. have received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies [other than trastuzumab] or mitomycin-c) prior to starting study drug or who have not recovered from side effects of such therapy
Descripción

Chemotherapy | Targeted Therapy Malignant Neoplasms | Nitrosoureas | Antibodies | Exception Trastuzumab | Mitomycin | Therapy Side effects Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0006826
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0003241
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0728747
UMLS CUI [6]
C0002475
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0879626
UMLS CUI [7,3]
C2004454
UMLS CUI [7,4]
C0332268
17. have received small molecule therapeutics (excluding monoclonal antibodies) ≤ 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy
Descripción

Small Molecule therapeutics | Exception Monoclonal Antibodies | Therapy Side effects Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1328819
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003250
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C2004454
UMLS CUI [3,4]
C0332268
18. have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Descripción

Extended-Field Radiation Therapy Disease palliation | Therapy Radiation Field Limited Disease palliation | Therapy Side effects Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3826855
UMLS CUI [1,2]
C0679251
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1882536
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0679251
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0879626
UMLS CUI [3,3]
C2004454
UMLS CUI [3,4]
C0332268
19. have undergone major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy
Descripción

Major surgery | Major surgery Side effects Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C2004454
UMLS CUI [2,4]
C0332268
20. known diagnosis of hiv infection
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
21. history of another malignancy within 3 years
Descripción

Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
22. patient is unable or unwilling to abide by the study protocol
Descripción

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
23. pregnant or breast feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Eligibility Breast Cancer NCT01589861

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. female or male ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
2. who performance status ≤ 1
boolean
C1298650 (UMLS CUI [1])
Locally advanced breast cancer HER2 Positive | Breast cancer recurrent HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive | Immunohistochemistry | FISH Positive | Trastuzumab failed
Item
3. locally advanced, recurrent or metastatic, histologically confirmed her2 positive (ihc 3+ or fish positive) breast cancer after failure of trastuzumab treatment.
boolean
C3495949 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3,1])
C2348909 (UMLS CUI [3,2])
C0021044 (UMLS CUI [4])
C0162789 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C0728747 (UMLS CUI [6,1])
C0231175 (UMLS CUI [6,2])
Trastuzumab Adjuvant therapy Neoplasm Metastasis | Trastuzumab Neoadjuvant Therapy Neoplasm Metastasis
Item
while on trastuzumab or within 4 weeks since the last infusion of trastuzumab for metastatic disease within 12 months of the last infusion for patients who received trastuzumab as adjuvant or neoadjuvant treatment
boolean
C0728747 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Disease Progression | trastuzumab
Item
4. for the phase ii part, progression on trastuzumab must have occurred within 16 weeks before entering this trial.
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Targeted Therapy Quantity HER2
Item
5. should not have received more than 3 lines of anti-her2 therapy.
boolean
C2985566 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
Activation PI3K/AKT1 Signaling Pathway
Item
6. for the phase ii part, activation of pi3k/akt pathway
boolean
C1879547 (UMLS CUI [1,1])
C2984369 (UMLS CUI [1,2])
Informed Consent
Item
7. capable of understanding the protocol and has signed the informed consent
boolean
C0021430 (UMLS CUI [1])
Normal Laboratory Test Result
Item
8. laboratory values within normal range
boolean
C0438214 (UMLS CUI [1])
Measurable Disease
Item
9. measurable disease
boolean
C1513041 (UMLS CUI [1])
Therapeutic procedure Metastatic malignant neoplasm to brain | Stable status Neurologic
Item
10. patients may have received treatment for brain metastases, but must be neurologically stable
boolean
C0087111 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
11. baseline lvef>50% (muga or echo)
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Affiliation Social Security Program
Item
12. affiliation to social security
boolean
C1510825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | lapatinib | neratinib | PI3K Inhibitor
Item
1. previous treatment with lapatinib, neratinib or a pi3k inhibitor
boolean
C1514463 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C2713008 (UMLS CUI [3])
C1519050 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Untreated
Item
2. untreated brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Liver disease | Kidney Disease | Pancreatitis | Chronic liver disease | Chronic Kidney Disease | Pancreatitis, Chronic
Item
3. acute or chronic liver, renal disease or pancreatitis
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C0341439 (UMLS CUI [4])
C1561643 (UMLS CUI [5])
C0149521 (UMLS CUI [6])
Peripheral Neuropathy CTCAE Grades
Item
4. any peripheral neuropathy ≥ ctcae grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mood Disorders | PHQ-9 | GAD-7 | Feeling suicidal PHQ-9
Item
5. any of the following mood disorders, or meets the cut-off score of ≥ 10 in the phq-9 or a cut-off of ≥ 15 in the gad-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the phq-9 (independent of the total score of the phq-9)
boolean
C0525045 (UMLS CUI [1])
C4083201 (UMLS CUI [2])
C3641330 (UMLS CUI [3])
C0424000 (UMLS CUI [4,1])
C4083201 (UMLS CUI [4,2])
Major depressive episode | Bipolar I disorder | Bipolar II disorder | Obsessive-Compulsive Disorder | Schizophrenia | Suicide attempt | Feeling suicidal | Homicidal thoughts | Risk of violence or harm to others
Item
medically documented history of or active major depressive episode, bipolar disorder (i or ii), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
boolean
C0024517 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
C0236788 (UMLS CUI [3])
C0028768 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0038663 (UMLS CUI [6])
C0424000 (UMLS CUI [7])
C0455204 (UMLS CUI [8])
C0549013 (UMLS CUI [9])
Anxiety CTCAE Grades
Item
≥ ctcae grade 3 anxiety
boolean
C0003467 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Diarrhea CTCAE Grades
Item
6. diarrhea ≥ ctcae grade 2
boolean
C0011991 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Heart Disease
Item
7. active cardiac disease
boolean
C0018799 (UMLS CUI [1])
Cardiac dysfunction
Item
8. history of cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
9. poorly controlled diabetes mellitus (hba1c > 8 %)
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Comorbidity Severe | Comorbidity Uncontrolled
Item
10. other severe and/or uncontrolled concomitant medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Abnormal digestive tract function Changing Absorption BKM120
Item
11. impairment of gastrointestinal function that may significantly alter the absorption of bkm120
boolean
C0232459 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C3491291 (UMLS CUI [1,4])
Colony-Stimulating Factors Hematopoietic
Item
12. been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
boolean
C0009392 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Pharmacotherapy At risk Prolonged QT interval | Pharmacotherapy Inducing Torsades de Pointes
Item
13. currently receiving treatment with medication with a known risk prolong the qt interval or inducing torsades de pointes
boolean
C0013216 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
CYP3A Inhibitors Moderate | CYP3A Inducers Moderate | CYP3A Inhibitors Strong | CYP3A Inducers Strong
Item
14. currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme cyp3a
boolean
C3850056 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3850056 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3850044 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
Steroids chronic | Immunosuppressive Agents chronic
Item
15. receiving chronic treatment with steroids or another immunosuppressive agent.
boolean
C0038317 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Chemotherapy | Targeted Therapy Malignant Neoplasms | Nitrosoureas | Antibodies | Exception Trastuzumab | Mitomycin | Therapy Side effects Recovery Lacking
Item
16. have received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies [other than trastuzumab] or mitomycin-c) prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C0392920 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0028210 (UMLS CUI [3])
C0003241 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0728747 (UMLS CUI [5,2])
C0002475 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0879626 (UMLS CUI [7,2])
C2004454 (UMLS CUI [7,3])
C0332268 (UMLS CUI [7,4])
Small Molecule therapeutics | Exception Monoclonal Antibodies | Therapy Side effects Recovery Lacking
Item
17. have received small molecule therapeutics (excluding monoclonal antibodies) ≤ 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C1328819 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
Extended-Field Radiation Therapy Disease palliation | Therapy Radiation Field Limited Disease palliation | Therapy Side effects Recovery Lacking
Item
18. have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C3826855 (UMLS CUI [1,1])
C0679251 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0679251 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
Major surgery | Major surgery Side effects Recovery Lacking
Item
19. have undergone major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C2004454 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
HIV Infection
Item
20. known diagnosis of hiv infection
boolean
C0019693 (UMLS CUI [1])
Cancer Other
Item
21. history of another malignancy within 3 years
boolean
C1707251 (UMLS CUI [1])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
22. patient is unable or unwilling to abide by the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
23. pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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