ID

30407

Beschreibung

Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00967044

Link

https://clinicaltrials.gov/show/NCT00967044

Stichworte

Versionen (1)
  1. 03.06.18 03.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Juni 2018

DOI

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Lizenz

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Eligibility Lymphoma NCT00967044

Englisch

Eligibility Lymphoma NCT00967044

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00967044
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed hodgkin or non hodgkin's lymphoma
Beschreibung

Hodgkin Disease | Lymphoma, Non-Hodgkin

Datentyp

boolean

Alias
UMLS CUI [1]
C0019829
UMLS CUI [2]
C0024305
2. relapsed or refractory after standard treatments and with no curative option with conventional therapy
Beschreibung

Recurrent disease Post Standard of Care | Refractory Disease Post Standard of Care | Absence Conventional Treatment Curative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2936643
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2936643
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C2945704
UMLS CUI [3,3]
C1276305
3. no evidence of cerebral or meningeal involvement by lymphoma
Beschreibung

Absence Brain Involvement with Lymphoma | Absence Meninges Involvement with Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0006104
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0024299
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0025285
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0024299
4. age >= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. eastern cooperative oncology group (ecog) performance status 0 to 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. life expectancy of at least 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. signed informed consent form prior to enrollment
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
8. patients must meet the following laboratory criteria: aspartate aminotransferase (ast)/serum glutamate oxaloacetate transaminase (sgot) and alt/serum glutamate pyruvate transaminase (sgpt) </= 2.5 * upper limit of normal (uln) ) or </= 5.0 x uln if the transaminase elevation is due to lymphoma involvement, serum bilirubin </= 1.5
Beschreibung

Laboratory criteria | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Involvement with Lymphoma | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0024299
UMLS CUI [5]
C1278039
* uln, serum creatinine </=1.5 * uln free t4 within normal limits (wnl) (patients may be on thyroid hormone replacement)
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
9. patients must have at least one measurable site of disease
Beschreibung

Disease Site Measurable Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1513040
UMLS CUI [1,4]
C1265611
10. adequate bone marrow function as shown by: absolute neutrophil count (anc) >/= 1.0 x 109/l, platelets >/=100 x 109/l
Beschreibung

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
11. fasting serum cholesterol </=300 mg/dl or </=7.75 mmol/l and fasting triglycerides </= 2.5 * uln. note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication 24 hours before starting therapy.
Beschreibung

Fasting cholesterol level

Datentyp

boolean

Alias
UMLS CUI [1]
C1282513
12. women of childbearing potential (wocbp) must have a negative serum pregnancy test within 7 days of the first administration of study drug
Beschreibung

Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included)
Beschreibung

Burkitt Lymphoma | Lymphoblastic lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0006413
UMLS CUI [2]
C0079748
UMLS CUI [3]
C0023434
UMLS CUI [4,1]
C0855095
UMLS CUI [4,2]
C0683607
2. chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0013230
3. previous radioimmunotherapy within 12 weeks
Beschreibung

Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0085101
4. prior therapy with hdac or [1] mammalian target of rapamycin (mtor) inhibitors i.e. temsirolimus, vorinostat (the list is not inclusive of investigational agents in these classes of drugs)
Beschreibung

Histone Deacetylase | mTOR Inhibitors | temsirolimus | Vorinostat

Datentyp

boolean

Alias
UMLS CUI [1]
C0019643
UMLS CUI [2]
C1515672
UMLS CUI [3]
C1707080
UMLS CUI [4]
C0672708
5. patient with known hiv infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
6. known active viral hepatitis
Beschreibung

Viral hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0042721
7. any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
Beschreibung

Disease Serious Interferes with Safety | Comorbidity Interferes with Safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0036043
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0036043
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
8. impaired cardiac function including any one of the following: • screening ecg with a corrected qt interval (qtc) > 450 msec confirmed by the investigator prior to enrollment to the study • patients with congenital long qt syndrome • history of sustained ventricular tachycardia • any history of ventricular fibrillation or torsades de pointes • bradycardia defined as heart rate < 50 beats per minute. patients with a pacemaker and heart rate >= 50 beats per minute are eligible.
Beschreibung

Decreased cardiac function | ECG: corrected QTc interval | Congenital long QT syndrome | Sustained ventricular tachycardia | Ventricular Fibrillation | Torsades de Pointes | Heart rate | Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C2216079
UMLS CUI [3]
C1141890
UMLS CUI [4]
C0750197
UMLS CUI [5]
C0042510
UMLS CUI [6]
C0040479
UMLS CUI [7]
C0018810
UMLS CUI [8]
C0030163
9. impaired cardiac function including any one of the following continued: • patients with a myocardial infarction or unstable angina within 6 months from registration on study • congestive heart failure (ny heart association class iii or iv) • right bundle branch block and left anterior hemiblock (bifascicular block) • uncontrolled hypertension
Beschreibung

Decreased cardiac function | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Right bundle branch block | Left anterior fascicular block | Bifascicular block | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0085615
UMLS CUI [6]
C0264912
UMLS CUI [7]
C0264914
UMLS CUI [8]
C1868885
10. concomitant use of drugs with a risk of causing torsades de pointes
Beschreibung

Pharmaceutical Preparations At risk Torsades de Pointes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
11. patients with unresolved diarrhea common toxicity criteria for adverse effects (ctcae) grade 1
Beschreibung

Diarrhea Resolution Lacking CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C0332268
UMLS CUI [1,4]
C1516728
12. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral panobinostat or everolimus.
Beschreibung

Abnormal digestive tract function | Gastrointestinal Disease Changing Drug absorption | Panobinostat Oral Product | Everolimus Oral Tablet

Datentyp

boolean

Alias
UMLS CUI [1]
C0232459
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0678745
UMLS CUI [3]
C3893181
UMLS CUI [4]
C2682853
13. female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. if barrier contraceptives are being used, these must be continued throughout the trial by both sexes. hormonal contraceptives are not acceptable as a sole method of contraception.
Beschreibung

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent | Contraception, Barrier | Hormonal contraception Solitary Unacceptable

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0004764
UMLS CUI [5,1]
C2985296
UMLS CUI [5,2]
C0205171
UMLS CUI [5,3]
C1883420
14. male patients whose sexual partners are wocbp not using effective birth control
Beschreibung

Gender | Sexual Partners Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0036911
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0332197
15. patients with a history of another primary malignancy within 5 years other than curatively treated cis of the cervix, basal or squamous cell carcinoma of the skin, or early stage prostate carcinoma.
Beschreibung

Cancer Other Primary | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Prostate carcinoma Early stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C2363430
16. patients with known positivity for human immunodeficiency virus (hiv) ) or hepatitis c; baseline testing for hiv and hepatitis c is not required
Beschreibung

HIV Seropositivity | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
17. patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
Beschreibung

Compliance behavior to medical regimen Lacking | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4039237
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
18. patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone <= 20 mg. topical or inhaled corticosteroids are allowed.
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Immunosuppressive Agents Systemic chronic | Exception Adrenal Cortex Hormones Dosage Daily | Prednisone Dosage Equivalent | Topical corticosteroids allowed | Adrenal Cortex Hormones Inhalation allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0332173
UMLS CUI [4,1]
C0032952
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205163
UMLS CUI [5,1]
C0304604
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0001617
UMLS CUI [6,2]
C0205535
UMLS CUI [6,3]
C0683607
19. patients should not receive immunization with attenuated live vaccines within one week of study registration or during study period
Beschreibung

Immunization Attenuated Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020971
UMLS CUI [1,2]
C0042211
20. chronic obstructive pulmonary disease (copd) or asthma requiring therapy
Beschreibung

Chronic Obstructive Airway Disease Treatment required for | Asthma Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0332121
21. uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln
Beschreibung

Diabetic - poor control | Elevated fasting glucose

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C1260439
22. active (acute or chronic) uncontrolled severe infection, requiring oral or intravenous antibiotics.
Beschreibung

Communicable Disease Severe Uncontrolled | Communicable Disease Severe Uncontrolled chronic | Requirement Antibiotics Oral | Requirement Antibiotics Intravenous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205318
UMLS CUI [2,4]
C0205191
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003232
UMLS CUI [3,3]
C1527415
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003232
UMLS CUI [4,3]
C1522726
23. patients receiving treatment on another clinical research trial.
Beschreibung

Study Subject Participation Status | Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0087111
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Ähnliche Modelle

Eligibility Lymphoma NCT00967044

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00967044
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hodgkin Disease | Lymphoma, Non-Hodgkin
Item
1. histologically confirmed hodgkin or non hodgkin's lymphoma
boolean
C0019829 (UMLS CUI [1])
C0024305 (UMLS CUI [2])
Recurrent disease Post Standard of Care | Refractory Disease Post Standard of Care | Absence Conventional Treatment Curative
Item
2. relapsed or refractory after standard treatments and with no curative option with conventional therapy
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C2945704 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
Absence Brain Involvement with Lymphoma | Absence Meninges Involvement with Lymphoma
Item
3. no evidence of cerebral or meningeal involvement by lymphoma
boolean
C0332197 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0024299 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0025285 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Age
Item
4. age >= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status 0 to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
7. signed informed consent form prior to enrollment
boolean
C0021430 (UMLS CUI [1])
Laboratory criteria | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Involvement with Lymphoma | Serum total bilirubin measurement
Item
8. patients must meet the following laboratory criteria: aspartate aminotransferase (ast)/serum glutamate oxaloacetate transaminase (sgot) and alt/serum glutamate pyruvate transaminase (sgpt) </= 2.5 * upper limit of normal (uln) ) or </= 5.0 x uln if the transaminase elevation is due to lymphoma involvement, serum bilirubin </= 1.5
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1314939 (UMLS CUI [4,1])
C0024299 (UMLS CUI [4,2])
C1278039 (UMLS CUI [5])
Creatinine measurement, serum
Item
* uln, serum creatinine </=1.5 * uln free t4 within normal limits (wnl) (patients may be on thyroid hormone replacement)
boolean
C0201976 (UMLS CUI [1])
Disease Site Measurable Quantity
Item
9. patients must have at least one measurable site of disease
boolean
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
10. adequate bone marrow function as shown by: absolute neutrophil count (anc) >/= 1.0 x 109/l, platelets >/=100 x 109/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Fasting cholesterol level
Item
11. fasting serum cholesterol </=300 mg/dl or </=7.75 mmol/l and fasting triglycerides </= 2.5 * uln. note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication 24 hours before starting therapy.
boolean
C1282513 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
12. women of childbearing potential (wocbp) must have a negative serum pregnancy test within 7 days of the first administration of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Burkitt Lymphoma | Lymphoblastic lymphoma | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma allowed
Item
1. burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included)
boolean
C0006413 (UMLS CUI [1])
C0079748 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
C0855095 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
2. chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Radioimmunotherapy
Item
3. previous radioimmunotherapy within 12 weeks
boolean
C0085101 (UMLS CUI [1])
Histone Deacetylase | mTOR Inhibitors | temsirolimus | Vorinostat
Item
4. prior therapy with hdac or [1] mammalian target of rapamycin (mtor) inhibitors i.e. temsirolimus, vorinostat (the list is not inclusive of investigational agents in these classes of drugs)
boolean
C0019643 (UMLS CUI [1])
C1515672 (UMLS CUI [2])
C1707080 (UMLS CUI [3])
C0672708 (UMLS CUI [4])
HIV Infection
Item
5. patient with known hiv infection
boolean
C0019693 (UMLS CUI [1])
Viral hepatitis
Item
6. known active viral hepatitis
boolean
C0042721 (UMLS CUI [1])
Disease Serious Interferes with Safety | Comorbidity Interferes with Safety | Disease Serious Interferes with Protocol Compliance | Comorbidity Interferes with Protocol Compliance
Item
7. any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Decreased cardiac function | ECG: corrected QTc interval | Congenital long QT syndrome | Sustained ventricular tachycardia | Ventricular Fibrillation | Torsades de Pointes | Heart rate | Artificial cardiac pacemaker
Item
8. impaired cardiac function including any one of the following: • screening ecg with a corrected qt interval (qtc) > 450 msec confirmed by the investigator prior to enrollment to the study • patients with congenital long qt syndrome • history of sustained ventricular tachycardia • any history of ventricular fibrillation or torsades de pointes • bradycardia defined as heart rate < 50 beats per minute. patients with a pacemaker and heart rate >= 50 beats per minute are eligible.
boolean
C0232166 (UMLS CUI [1])
C2216079 (UMLS CUI [2])
C1141890 (UMLS CUI [3])
C0750197 (UMLS CUI [4])
C0042510 (UMLS CUI [5])
C0040479 (UMLS CUI [6])
C0018810 (UMLS CUI [7])
C0030163 (UMLS CUI [8])
Decreased cardiac function | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Right bundle branch block | Left anterior fascicular block | Bifascicular block | Uncontrolled hypertension
Item
9. impaired cardiac function including any one of the following continued: • patients with a myocardial infarction or unstable angina within 6 months from registration on study • congestive heart failure (ny heart association class iii or iv) • right bundle branch block and left anterior hemiblock (bifascicular block) • uncontrolled hypertension
boolean
C0232166 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0085615 (UMLS CUI [5])
C0264912 (UMLS CUI [6])
C0264914 (UMLS CUI [7])
C1868885 (UMLS CUI [8])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
10. concomitant use of drugs with a risk of causing torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Diarrhea Resolution Lacking CTCAE Grades
Item
11. patients with unresolved diarrhea common toxicity criteria for adverse effects (ctcae) grade 1
boolean
C0011991 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
Abnormal digestive tract function | Gastrointestinal Disease Changing Drug absorption | Panobinostat Oral Product | Everolimus Oral Tablet
Item
12. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral panobinostat or everolimus.
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
C3893181 (UMLS CUI [3])
C2682853 (UMLS CUI [4])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent | Contraception, Barrier | Hormonal contraception Solitary Unacceptable
Item
13. female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. if barrier contraceptives are being used, these must be continued throughout the trial by both sexes. hormonal contraceptives are not acceptable as a sole method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0004764 (UMLS CUI [4])
C2985296 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C1883420 (UMLS CUI [5,3])
Gender | Sexual Partners Childbearing Potential Contraceptive methods Absent
Item
14. male patients whose sexual partners are wocbp not using effective birth control
boolean
C0079399 (UMLS CUI [1])
C0036911 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Cancer Other Primary | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Prostate carcinoma Early stage
Item
15. patients with a history of another primary malignancy within 5 years other than curatively treated cis of the cervix, basal or squamous cell carcinoma of the skin, or early stage prostate carcinoma.
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0553723 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C2363430 (UMLS CUI [5,3])
HIV Seropositivity | Hepatitis C positive
Item
16. patients with known positivity for human immunodeficiency virus (hiv) ) or hepatitis c; baseline testing for hiv and hepatitis c is not required
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Compliance behavior to medical regimen Lacking | Informed Consent Unable
Item
17. patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
boolean
C4039237 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Immunosuppressive Agents Systemic chronic | Exception Adrenal Cortex Hormones Dosage Daily | Prednisone Dosage Equivalent | Topical corticosteroids allowed | Adrenal Cortex Hormones Inhalation allowed
Item
18. patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone <= 20 mg. topical or inhaled corticosteroids are allowed.
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0332173 (UMLS CUI [3,4])
C0032952 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
C0304604 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0001617 (UMLS CUI [6,1])
C0205535 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Immunization Attenuated Vaccines
Item
19. patients should not receive immunization with attenuated live vaccines within one week of study registration or during study period
boolean
C0020971 (UMLS CUI [1,1])
C0042211 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease Treatment required for | Asthma Treatment required for
Item
20. chronic obstructive pulmonary disease (copd) or asthma requiring therapy
boolean
C0024117 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Diabetic - poor control | Elevated fasting glucose
Item
21. uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln
boolean
C0421258 (UMLS CUI [1])
C1260439 (UMLS CUI [2])
Communicable Disease Severe Uncontrolled | Communicable Disease Severe Uncontrolled chronic | Requirement Antibiotics Oral | Requirement Antibiotics Intravenous
Item
22. active (acute or chronic) uncontrolled severe infection, requiring oral or intravenous antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C1514873 (UMLS CUI [3,1])
C0003232 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0003232 (UMLS CUI [4,2])
C1522726 (UMLS CUI [4,3])
Study Subject Participation Status | Therapeutic procedure
Item
23. patients receiving treatment on another clinical research trial.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
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