ID

23483

Descrição

Responsible Party: Prof. Dr. Juergen Wolf, Professor Dr. med., Leader of the LCGC, University of Cologne ClinicalTrials.gov Identifier: NCT02183870 History of Changes Other Study ID Numbers: EUCROSS 2013-002737-38 ( EudraCT Number ) DRKS00005409 ( Other Identifier: DRKS ) Study First Received: June 25, 2014 Last Updated: December 7, 2015 EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer (EUCROSS) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02183870

Link

https://clinicaltrials.gov/ct2/show/NCT02183870

Palavras-chave

Versões (1)
  1. 07/07/2017 07/07/2017 -
Transferido a

7 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT02183870 DRKS00005409

Inglês

Eligibility Lung Cancer NCT02183870 DRKS00005409

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Patients with adenocarcinoma of the lung that is locally advanced or metastatic independent from the number of prior lines of therapy, i.e. including non-pretreated patients (UICC stage IIIB or IV)
Descrição

Lung Cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242379
Positive for ROS1 translocation by central FISH-testing
Descrição

ROS1 translocation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0812281
Ability to swallow pills
Descrição

Ability to swallow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0566355
Age > 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ECOG performance status 0 to 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Life expectancy of at least 12 weeks
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
Descrição

Response Evaluation Criteria in Solid Tumors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1709926
Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to initiation of study medication
Descrição

Prior Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to screening:
Descrição

Bone Marrow, Liver and Renal Function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0005953
UMLS CUI [3]
C0232804
Hemoglobin ≥ 8.0 g/dL
Descrição

Hemoglobin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019046
Absolute neutrophil count (ANC) ≥ 1,000 /mm3
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
Platelet count ≥ 50 000/µL
Descrição

Platelet count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005821
Total bilirubin ≤ 2 x upper limit of normal (ULN)
Descrição

Total bilirubin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201913
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) ≤ 2,5 x ULN or ≤ 5 x ULN in case of liver involvement
Descrição

ALT, AST, AP

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201850
PT-INR/PTT ≤ 1.5 x ULN
Descrição

INR

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525032
Serum creatinine ≤ 2 times ULN
Descrição

Creatinine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
Calculated creatinine clearance (CLcr) ≥ 40 ml/min (Cockcroft-Gault formula)
Descrição

Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2924627
Written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Negative serum pregnancy test within 3 days prior to start of dosing premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
Descrição

Pregnancy Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032976
Fertile men and women must have an effective method of contraception during treatment and for at least 3 months after completion of treatment as directed by their physician. Effective methods of contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence where lifestyle of the patient ensures compliance (Periodic abstinence and withdrawal are not acceptable methods of contraception).
Descrição

Contraceptive Methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Previous treatment with specific ALK or ROS1 inhibitors
Descrição

ALK or ROS1 inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3640935
UMLS CUI [2]
C0812281
Current treatment within another therapeutic clinical trial
Descrição

Study Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
Other history of ongoing malignancy that would potentially interfere with the interpretation of efficacy (early stage or chronic disease is allowed if not requiring active therapy or intervention and being under control)
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
Pregnancy or breastfeeding
Descrição

Gynaecological Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole and grapefruit or grapefruit juice
Descrição

CYP3A4 inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3830624
Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort
Descrição

CYP3A4 inducers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850041
Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine
Descrição

CYP3A4 substrates

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1142644
UMLS CUI [1,2]
C3891814
Active CNS metastases. Patients with brain metastasis are eligible if asymptomatic for ≥ 14 days before starting study medication and off corticosteroids.
Descrição

CNS metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
History of or known carcinomatous meningitis or leptomeningeal disease
Descrição

Carcinomatous meningitis or leptomeningeal disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2]
C0751297
Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)
Descrição

HIV, HBV, HCV

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
Any person being in an institution on assignment of the respective authority against his/her own will
Descrição

Institutionalization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021629
Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval > 470ms
Descrição

Cardiac dysrhythmias, Atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3844448
UMLS CUI [2]
C0004238
Patients with known interstitial fibrosis or interstitial lung disease
Descrição

Interstitial fibrosis or interstitial lung disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0240035
UMLS CUI [2]
C0206062
Any of the following within 3 months prior to first crizotinib administration: Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
Descrição

Myocardial infarction, Angina, Congestive heart failure, Cerebrovascular accident, Transient ischemic attack

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
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Similar models

Eligibility Lung Cancer NCT02183870 DRKS00005409

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
Lung Cancer
Item
Patients with adenocarcinoma of the lung that is locally advanced or metastatic independent from the number of prior lines of therapy, i.e. including non-pretreated patients (UICC stage IIIB or IV)
boolean
C0242379 (UMLS CUI [1])
ROS1 translocation
Item
Positive for ROS1 translocation by central FISH-testing
boolean
C0812281 (UMLS CUI [1])
Ability to swallow
Item
Ability to swallow pills
boolean
C0566355 (UMLS CUI [1])
Age
Item
Age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ECOG performance status 0 to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
Life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Response Evaluation Criteria in Solid Tumors
Item
Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
boolean
C1709926 (UMLS CUI [1])
Prior Therapy
Item
Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to initiation of study medication
boolean
C1514463 (UMLS CUI [1])
Bone Marrow, Liver and Renal Function
Item
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to screening:
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Hemoglobin
Item
Hemoglobin ≥ 8.0 g/dL
boolean
C0019046 (UMLS CUI [1])
Absolute neutrophil count
Item
Absolute neutrophil count (ANC) ≥ 1,000 /mm3
boolean
C0948762 (UMLS CUI [1])
Platelet count
Item
Platelet count ≥ 50 000/µL
boolean
C0005821 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin ≤ 2 x upper limit of normal (ULN)
boolean
C0201913 (UMLS CUI [1])
ALT, AST, AP
Item
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) ≤ 2,5 x ULN or ≤ 5 x ULN in case of liver involvement
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
INR
Item
PT-INR/PTT ≤ 1.5 x ULN
boolean
C0525032 (UMLS CUI [1])
Creatinine
Item
Serum creatinine ≤ 2 times ULN
boolean
C0201976 (UMLS CUI [1])
Cockcroft-Gault formula
Item
Calculated creatinine clearance (CLcr) ≥ 40 ml/min (Cockcroft-Gault formula)
boolean
C2924627 (UMLS CUI [1])
Informed Consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy Test
Item
Negative serum pregnancy test within 3 days prior to start of dosing premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
boolean
C0032976 (UMLS CUI [1])
Contraceptive Methods
Item
Fertile men and women must have an effective method of contraception during treatment and for at least 3 months after completion of treatment as directed by their physician. Effective methods of contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence where lifestyle of the patient ensures compliance (Periodic abstinence and withdrawal are not acceptable methods of contraception).
boolean
C0700589 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
ALK or ROS1 inhibitors
Item
Previous treatment with specific ALK or ROS1 inhibitors
boolean
C3640935 (UMLS CUI [1])
C0812281 (UMLS CUI [2])
Study Participation Status
Item
Current treatment within another therapeutic clinical trial
boolean
C2348568 (UMLS CUI [1])
Malignant Neoplasms
Item
Other history of ongoing malignancy that would potentially interfere with the interpretation of efficacy (early stage or chronic disease is allowed if not requiring active therapy or intervention and being under control)
boolean
C0006826 (UMLS CUI [1])
Gynaecological Status
Item
Pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
CYP3A4 inhibitors
Item
Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole and grapefruit or grapefruit juice
boolean
C3830624 (UMLS CUI [1])
CYP3A4 inducers
Item
Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort
boolean
C3850041 (UMLS CUI [1])
CYP3A4 substrates
Item
Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine
boolean
C1142644 (UMLS CUI [1,1])
C3891814 (UMLS CUI [1,2])
CNS metastases
Item
Active CNS metastases. Patients with brain metastasis are eligible if asymptomatic for ≥ 14 days before starting study medication and off corticosteroids.
boolean
C0686377 (UMLS CUI [1])
Carcinomatous meningitis or leptomeningeal disease
Item
History of or known carcinomatous meningitis or leptomeningeal disease
boolean
C0220654 (UMLS CUI [1])
C0751297 (UMLS CUI [2])
HIV, HBV, HCV
Item
Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Institutionalization
Item
Any person being in an institution on assignment of the respective authority against his/her own will
boolean
C0021629 (UMLS CUI [1])
Comorbidity
Item
Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
boolean
C0009488 (UMLS CUI [1])
Cardiac dysrhythmias, Atrial fibrillation
Item
Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval > 470ms
boolean
C3844448 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
Interstitial fibrosis or interstitial lung disease
Item
Patients with known interstitial fibrosis or interstitial lung disease
boolean
C0240035 (UMLS CUI [1])
C0206062 (UMLS CUI [2])
Myocardial infarction, Angina, Congestive heart failure, Cerebrovascular accident, Transient ischemic attack
Item
Any of the following within 3 months prior to first crizotinib administration: Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
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