ID

35193

Beskrivning

Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01562301

Länk

https://clinicaltrials.gov/show/NCT01562301

Nyckelord

Versioner (1)
  1. 2019-02-23 2019-02-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chemotherapeutic Agent Toxicity NCT01562301

Engelsk

Eligibility Chemotherapeutic Agent Toxicity NCT01562301

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed diagnosed advanced non-small cell lung cancer (stage iiib and iv) and be scheduled to receive four cycles of carboplatin and docetaxel chemotherapy.
Beskrivning

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Chemotherapy cycle Quantity Scheduled | Carboplatin | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205539
UMLS CUI [3]
C0079083
UMLS CUI [4]
C0246415
2. newly diagnosed or previously treated patient with nsclc. previously treated patients are allowed to have any previous chemotherapy for the treatment of nsclc.
Beskrivning

Non-Small Cell Lung Carcinoma Newly Diagnosed | Prior Therapy Non-Small Cell Lung Carcinoma | Prior Chemotherapy Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0007131
3. age >18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status < or =2 (karnofsky > or = 60%)
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
5. life expectancy of greater than 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. patients must have normal organ and marrow function as defined below: - leukocytes > or = 3,000/mcl - absolute neutrophil count > or = 1,500/mcl - platelets > or = 100,000/mcl - total bilirubin within normal institutional limits -
Beskrivning

Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum bilirubin normal

Datatyp

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]
C0032181
UMLS CUI [6]
C0428443
ast(sgot)/alt(sgpt) < or = 2.5 x institutional upper limit of normal - creatinine within normal institutional limits or - creatinine clearance > or = 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0438244
UMLS CUI [4]
C0373595
UMLS CUI [5]
C0700225
7. negative serum or urine pregnancy test in women of child-bearing potential
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
8. scheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days
Beskrivning

Chemotherapy Scheduled | Carboplatin | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0079083
UMLS CUI [3]
C0246415
9. the effects of anvirzel on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Beskrivning

Anvirzel | Fetus drug adverse effect Unknown | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1]
C0967809
UMLS CUI [2,1]
C0920518
UMLS CUI [2,2]
C0439673
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0036899
10. ability to understand and the willingness to sign a written informed consent document
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients receiving any other investigational agents
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
2. history of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides
Beskrivning

Allergic Reaction Compound Cardiac Glycosides Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0007158
UMLS CUI [1,4]
C2348205
3. patients receiving any medications or substances that are inhibitors or inducers of cyp 3a4 are ineligible
Beskrivning

CYP3A4 Inhibitor | CYP3A4 Inducer

Datatyp

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3830625
4. 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
Beskrivning

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
5. pregnant or breastfeeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. hiv-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with anvirzel. in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Beskrivning

HIV Seropositivity | Antiretroviral therapy Combined | Drug Interaction potential Anvirzel | Patients At risk Communicable Disease Lethal | Relationship Therapeutic Bone Marrow Suppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C0205195
UMLS CUI [3,1]
C0687133
UMLS CUI [3,2]
C3245505
UMLS CUI [3,3]
C0967809
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0009450
UMLS CUI [4,4]
C3151529
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C2698538
7. uncontrolled or significant cardiovascular disease, including: • myocardial infarction within 6 months • uncontrolled angina within 6 months • newly diagnosed congestive heart failure within 6 months, defined as nyhc-ii or currently uncontrolled congestive heart failure • diagnosed or suspected congenital long qt syndrome • any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, wolff-parkinson-white (wpw) syndrome, or torsade de pointes). prolonged qtc interval on pre-entry electrocardiogram (> 450 msec). if the automated reading is prolonged (i.e., > 450 msec), the ekg should be manually over-read • any history of second or third degree heart block • heart rate < 50 beats/minute or sustained heart rate > 110 on pre-entry electrocardiogram • newly diagnosed atrial fibrillation within 6 months or currently uncontrolled atrial fibrillation • uncontrolled hypertension defined as sustained blood pressure of >/= 140/90mm hg
Beskrivning

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant | Myocardial Infarction | Angina Pectoris Uncontrolled | Congestive heart failure New York Heart Association Classification | Congestive heart failure Uncontrolled | Congenital long QT syndrome Suspected | Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation | Wolff-Parkinson-White Syndrome | Torsades de Pointes | Prolonged QTc interval on electrocardiogram (ECG) | Second degree atrioventricular block | Complete atrioventricular block | Heart rate | Heart rate Sustained Electrocardiogram | Atrial Fibrillation | ATRIAL FIBRILLATION UNCONTROLLED | Uncontrolled hypertension | Blood Pressure Sustained

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C1141890
UMLS CUI [7,2]
C0750491
UMLS CUI [8]
C0085612
UMLS CUI [9]
C0042514
UMLS CUI [10]
C0042510
UMLS CUI [11]
C0043202
UMLS CUI [12]
C0040479
UMLS CUI [13]
C4015677
UMLS CUI [14]
C0264906
UMLS CUI [15]
C0151517
UMLS CUI [16]
C0018810
UMLS CUI [17,1]
C0018810
UMLS CUI [17,2]
C0443318
UMLS CUI [17,3]
C0013798
UMLS CUI [18]
C0004238
UMLS CUI [19]
C0741284
UMLS CUI [20]
C1868885
UMLS CUI [21,1]
C0005823
UMLS CUI [21,2]
C0443318
8. current use of a pacemaker
Beskrivning

Artificial cardiac pacemaker

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
9. patients using or scheduled to use bevacizumab during study period
Beskrivning

Bevacizumab | Bevacizumab Scheduled

Datatyp

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2,1]
C0796392
UMLS CUI [2,2]
C0205539
10. current use of cardiac glycoside
Beskrivning

Cardiac Glycoside

Datatyp

boolean

Alias
UMLS CUI [1]
C0007158
Tillbaka till toppen

Similar models

Eligibility Chemotherapeutic Agent Toxicity NCT01562301

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Chemotherapy cycle Quantity Scheduled | Carboplatin | docetaxel
Item
1. patients must have histologically or cytologically confirmed diagnosed advanced non-small cell lung cancer (stage iiib and iv) and be scheduled to receive four cycles of carboplatin and docetaxel chemotherapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0079083 (UMLS CUI [3])
C0246415 (UMLS CUI [4])
Non-Small Cell Lung Carcinoma Newly Diagnosed | Prior Therapy Non-Small Cell Lung Carcinoma | Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
2. newly diagnosed or previously treated patient with nsclc. previously treated patients are allowed to have any previous chemotherapy for the treatment of nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
Age
Item
3. age >18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
4. ecog performance status < or =2 (karnofsky > or = 60%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
5. life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum bilirubin normal
Item
6. patients must have normal organ and marrow function as defined below: - leukocytes > or = 3,000/mcl - absolute neutrophil count > or = 1,500/mcl - platelets > or = 100,000/mcl - total bilirubin within normal institutional limits -
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0428443 (UMLS CUI [6])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised
Item
ast(sgot)/alt(sgpt) < or = 2.5 x institutional upper limit of normal - creatinine within normal institutional limits or - creatinine clearance > or = 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0438244 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
7. negative serum or urine pregnancy test in women of child-bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Chemotherapy Scheduled | Carboplatin | docetaxel
Item
8. scheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0079083 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Anvirzel | Fetus drug adverse effect Unknown | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
9. the effects of anvirzel on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0967809 (UMLS CUI [1])
C0920518 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
Informed Consent
Item
10. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
1. patients receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Allergic Reaction Compound Cardiac Glycosides Similar
Item
2. history of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0007158 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
CYP3A4 Inhibitor | CYP3A4 Inducer
Item
3. patients receiving any medications or substances that are inhibitors or inducers of cyp 3a4 are ineligible
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
4. 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])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
5. pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Antiretroviral therapy Combined | Drug Interaction potential Anvirzel | Patients At risk Communicable Disease Lethal | Relationship Therapeutic Bone Marrow Suppression
Item
6. hiv-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with anvirzel. in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0687133 (UMLS CUI [3,1])
C3245505 (UMLS CUI [3,2])
C0967809 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0009450 (UMLS CUI [4,3])
C3151529 (UMLS CUI [4,4])
C0439849 (UMLS CUI [5,1])
C2698538 (UMLS CUI [5,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant | Myocardial Infarction | Angina Pectoris Uncontrolled | Congestive heart failure New York Heart Association Classification | Congestive heart failure Uncontrolled | Congenital long QT syndrome Suspected | Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation | Wolff-Parkinson-White Syndrome | Torsades de Pointes | Prolonged QTc interval on electrocardiogram (ECG) | Second degree atrioventricular block | Complete atrioventricular block | Heart rate | Heart rate Sustained Electrocardiogram | Atrial Fibrillation | ATRIAL FIBRILLATION UNCONTROLLED | Uncontrolled hypertension | Blood Pressure Sustained
Item
7. uncontrolled or significant cardiovascular disease, including: • myocardial infarction within 6 months • uncontrolled angina within 6 months • newly diagnosed congestive heart failure within 6 months, defined as nyhc-ii or currently uncontrolled congestive heart failure • diagnosed or suspected congenital long qt syndrome • any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, wolff-parkinson-white (wpw) syndrome, or torsade de pointes). prolonged qtc interval on pre-entry electrocardiogram (> 450 msec). if the automated reading is prolonged (i.e., > 450 msec), the ekg should be manually over-read • any history of second or third degree heart block • heart rate < 50 beats/minute or sustained heart rate > 110 on pre-entry electrocardiogram • newly diagnosed atrial fibrillation within 6 months or currently uncontrolled atrial fibrillation • uncontrolled hypertension defined as sustained blood pressure of >/= 140/90mm hg
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0018802 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C1141890 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0085612 (UMLS CUI [8])
C0042514 (UMLS CUI [9])
C0042510 (UMLS CUI [10])
C0043202 (UMLS CUI [11])
C0040479 (UMLS CUI [12])
C4015677 (UMLS CUI [13])
C0264906 (UMLS CUI [14])
C0151517 (UMLS CUI [15])
C0018810 (UMLS CUI [16])
C0018810 (UMLS CUI [17,1])
C0443318 (UMLS CUI [17,2])
C0013798 (UMLS CUI [17,3])
C0004238 (UMLS CUI [18])
C0741284 (UMLS CUI [19])
C1868885 (UMLS CUI [20])
C0005823 (UMLS CUI [21,1])
C0443318 (UMLS CUI [21,2])
Artificial cardiac pacemaker
Item
8. current use of a pacemaker
boolean
C0030163 (UMLS CUI [1])
Bevacizumab | Bevacizumab Scheduled
Item
9. patients using or scheduled to use bevacizumab during study period
boolean
C0796392 (UMLS CUI [1])
C0796392 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Cardiac Glycoside
Item
10. current use of cardiac glycoside
boolean
C0007158 (UMLS CUI [1])
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