ID

36598

Descripción

A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01500824

Link

https://clinicaltrials.gov/show/NCT01500824

Palabras clave

Versiones (1)
  1. 25/5/19 25/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

25 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT01500824

Inglés

Eligibility Non-Small Cell Lung Cancer NCT01500824

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
Descripción

Non-squamous non-small cell lung cancer Advanced Locally | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C4288755
positive for translocation or inversion events involving the alk gene locus
Descripción

Translocation Involving ALK gene | Inversion Involving ALK gene

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040715
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1332080
UMLS CUI [2,1]
C0021943
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C1332080
patients must have had progressive disease after only one prior chemotherapy regimen. this regimen must have been platinum-based and may have included maintenance therapy.
Descripción

Progressive Disease | Status post Prior Chemotherapy Platinum-Based | Maintenance therapy Included

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514457
UMLS CUI [2,3]
C1514162
UMLS CUI [3,1]
C0677908
UMLS CUI [3,2]
C0332257
evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
Descripción

Informed Consent | Informed Consent Patient Representative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
current treatment on another therapeutic clinical trial.
Descripción

Study Subject Participation Status | Therapeutic Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1515364
prior therapy directly targeting alk.
Descripción

ALK Targeted Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1332080
UMLS CUI [1,2]
C2985566
any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
Descripción

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C3495795
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007787
ongoing cardiac dysrhythmias of nci ctcae grade >=2, uncontrolled atrial fibrillation of any grade, or qtc interval >470 msec.
Descripción

Cardiac Arrhythmia CTCAE Grades | ATRIAL FIBRILLATION UNCONTROLLED Grade | Prolonged QTc interval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0741284
UMLS CUI [2,2]
C0441800
UMLS CUI [3]
C1560305
pregnancy or breastfeeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of drugs or foods that are known potent cyp3a inducers/inhibitors/substrates with narrow therapeutic indices.
Descripción

CYP3A Inducers Strong Narrow Therapeutic Index | CYP3A Inhibitors Strong Narrow Therapeutic Index | CYP3A Substrate Strong Narrow Therapeutic Index

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3850044
UMLS CUI [1,2]
C0442821
UMLS CUI [1,3]
C3889681
UMLS CUI [2,1]
C3850056
UMLS CUI [2,2]
C0442821
UMLS CUI [2,3]
C3889681
UMLS CUI [3,1]
C0059563
UMLS CUI [3,2]
C3891814
UMLS CUI [3,3]
C0442821
UMLS CUI [3,4]
C3889681
known hiv infection
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
known interstitial lung disease or interstitial fibrosis
Descripción

Lung Disease, Interstitial | Interstitial lung fibrosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C3887486
other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
Descripción

Other medical condition Severe Study Subject Participation Status High risk | Other medical condition chronic Study Subject Participation Status High risk | Gastrointestinal Diseases | Diarrhea | Peptic Ulcer | Other medical condition Severe Investigational New Drugs High risk | Other medical condition chronic Investigational New Drugs High risk | Other medical condition Severe Study Subject Participation Status Inappropriate | Other medical condition chronic Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status High risk | Mental condition Investigational New Drugs High risk | Mental condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status High risk | Laboratory test result abnormal Investigational New Drugs High risk | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C4319571
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C4319571
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0011991
UMLS CUI [5]
C0030920
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0013230
UMLS CUI [6,4]
C4319571
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0205191
UMLS CUI [7,3]
C0013230
UMLS CUI [7,4]
C4319571
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C2348568
UMLS CUI [8,4]
C1548788
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0205191
UMLS CUI [9,3]
C2348568
UMLS CUI [9,4]
C1548788
UMLS CUI [10,1]
C3840291
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C4319571
UMLS CUI [11,1]
C3840291
UMLS CUI [11,2]
C0013230
UMLS CUI [11,3]
C4319571
UMLS CUI [12,1]
C3840291
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C1548788
UMLS CUI [13,1]
C0438215
UMLS CUI [13,2]
C2348568
UMLS CUI [13,3]
C4319571
UMLS CUI [14,1]
C0438215
UMLS CUI [14,2]
C0013230
UMLS CUI [14,3]
C4319571
UMLS CUI [15,1]
C0438215
UMLS CUI [15,2]
C2348568
UMLS CUI [15,3]
C1548788
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT01500824

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-squamous non-small cell lung cancer Advanced Locally | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Item
proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
boolean
C4324656 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C4288755 (UMLS CUI [2])
Translocation Involving ALK gene | Inversion Involving ALK gene
Item
positive for translocation or inversion events involving the alk gene locus
boolean
C0040715 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1332080 (UMLS CUI [1,3])
C0021943 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1332080 (UMLS CUI [2,3])
Progressive Disease | Status post Prior Chemotherapy Platinum-Based | Maintenance therapy Included
Item
patients must have had progressive disease after only one prior chemotherapy regimen. this regimen must have been platinum-based and may have included maintenance therapy.
boolean
C1335499 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
C0677908 (UMLS CUI [3,1])
C0332257 (UMLS CUI [3,2])
Informed Consent | Informed Consent Patient Representative
Item
evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Therapeutic Clinical Trial
Item
current treatment on another therapeutic clinical trial.
boolean
C2348568 (UMLS CUI [1])
C1515364 (UMLS CUI [2])
ALK Targeted Therapy
Item
prior therapy directly targeting alk.
boolean
C1332080 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack
Item
any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C3495795 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
Cardiac Arrhythmia CTCAE Grades | ATRIAL FIBRILLATION UNCONTROLLED Grade | Prolonged QTc interval
Item
ongoing cardiac dysrhythmias of nci ctcae grade >=2, uncontrolled atrial fibrillation of any grade, or qtc interval >470 msec.
boolean
C0003811 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0741284 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C1560305 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
CYP3A Inducers Strong Narrow Therapeutic Index | CYP3A Inhibitors Strong Narrow Therapeutic Index | CYP3A Substrate Strong Narrow Therapeutic Index
Item
use of drugs or foods that are known potent cyp3a inducers/inhibitors/substrates with narrow therapeutic indices.
boolean
C3850044 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3889681 (UMLS CUI [1,3])
C3850056 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3889681 (UMLS CUI [2,3])
C0059563 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0442821 (UMLS CUI [3,3])
C3889681 (UMLS CUI [3,4])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
Lung Disease, Interstitial | Interstitial lung fibrosis
Item
known interstitial lung disease or interstitial fibrosis
boolean
C0206062 (UMLS CUI [1])
C3887486 (UMLS CUI [2])
Other medical condition Severe Study Subject Participation Status High risk | Other medical condition chronic Study Subject Participation Status High risk | Gastrointestinal Diseases | Diarrhea | Peptic Ulcer | Other medical condition Severe Investigational New Drugs High risk | Other medical condition chronic Investigational New Drugs High risk | Other medical condition Severe Study Subject Participation Status Inappropriate | Other medical condition chronic Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status High risk | Mental condition Investigational New Drugs High risk | Mental condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status High risk | Laboratory test result abnormal Investigational New Drugs High risk | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C4319571 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C4319571 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3])
C0011991 (UMLS CUI [4])
C0030920 (UMLS CUI [5])
C3843040 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
C4319571 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0013230 (UMLS CUI [7,3])
C4319571 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C1548788 (UMLS CUI [8,4])
C3843040 (UMLS CUI [9,1])
C0205191 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C1548788 (UMLS CUI [9,4])
C3840291 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C4319571 (UMLS CUI [10,3])
C3840291 (UMLS CUI [11,1])
C0013230 (UMLS CUI [11,2])
C4319571 (UMLS CUI [11,3])
C3840291 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
C0438215 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C4319571 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C4319571 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C2348568 (UMLS CUI [15,2])
C1548788 (UMLS CUI [15,3])
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