ID

20174

Beschreibung

Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00302016

Link

https://clinicaltrials.gov/show/NCT00302016

Stichworte

Versionen (1)
  1. 09.02.17 09.02.17 -
Hochgeladen am

9. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT00302016

Englisch

Eligibility Chronic Myeloid Leukemia NCT00302016

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
imatinib-resistant or -intolerant philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase.
Beschreibung

Philadelphia chromosome positive chronic myelogenous leukemia Imatinib Resistant | Philadelphia chromosome positive chronic myelogenous leukemia imatinib intolerant | Philadelphia chromosome positive chronic myelogenous leukemia Blast Phase | Philadelphia chromosome positive chronic myelogenous leukemia Accelerated phase | Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0935989
UMLS CUI [1,3]
C0332325
UMLS CUI [2,1]
C0279543
UMLS CUI [2,2]
C0935989
UMLS CUI [2,3]
C0231200
UMLS CUI [3,1]
C0279543
UMLS CUI [3,2]
C0005699
UMLS CUI [4,1]
C0279543
UMLS CUI [4,2]
C0457345
UMLS CUI [5,1]
C0279543
UMLS CUI [5,2]
C0457343
chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor.
Beschreibung

Tyrosine kinase inhibitor Investigational Chronic Myeloid Leukemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1268567
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C0023473
laboratory values within normal limits.
Beschreibung

Normal Laboratory Test Result

Datentyp

boolean

Alias
UMLS CUI [1]
C0438214
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired cardiac function.
Beschreibung

Decreased cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232166
acute or chronic liver or renal disease considered unrelated to tumor.
Beschreibung

Liver disease Neoplasm Relationship | Kidney Disease Neoplasm Relationship | Chronic liver disease Neoplasm Relationship | Chronic Kidney Disease Neoplasm Relationship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0341439
UMLS CUI [3,2]
C0027651
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C1561643
UMLS CUI [4,2]
C0027651
UMLS CUI [4,3]
C0439849
other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
Beschreibung

Medical condition Severe Causing Safety Risk | Medical condition Uncontrolled Causing Safety Risk | Medical condition Severe Protocol Compliance Limited | Medical condition Uncontrolled Protocol Compliance Limited | Diabetic - poor control | Communicable Diseases | Communicable Diseases Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0036043
UMLS CUI [1,5]
C0035647
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0678227
UMLS CUI [2,4]
C0036043
UMLS CUI [2,5]
C0035647
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0525058
UMLS CUI [3,4]
C0439801
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0525058
UMLS CUI [4,4]
C0439801
UMLS CUI [5]
C0421258
UMLS CUI [6]
C0009450
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0205318
patients who are currently receiving treatment with any of the medications that have the potential to prolong the qt interval or to inhibit the metabolism of amn107 (cyp3a4/5 inhibitors).
Beschreibung

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Preventing Metabolism AMN107 | CYP3A4 Inhibitors | CYP3A5 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0025519
UMLS CUI [2,4]
C1567379
UMLS CUI [3]
C3850053
UMLS CUI [4]
C3850054
patients with a history of another malignancy that is currently clinically significant or currently requires active intervention.
Beschreibung

Malignant Neoplasm Clinical Significance | Malignant Neoplasm Requirement Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184661
other protocol-defined inclusion/exclusion criteria may apply.
Beschreibung

Clinical Trial Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Chronic Myeloid Leukemia NCT00302016

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia Imatinib Resistant | Philadelphia chromosome positive chronic myelogenous leukemia imatinib intolerant | Philadelphia chromosome positive chronic myelogenous leukemia Blast Phase | Philadelphia chromosome positive chronic myelogenous leukemia Accelerated phase | Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase
Item
imatinib-resistant or -intolerant philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase.
boolean
C0279543 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
C0279543 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
C0231200 (UMLS CUI [2,3])
C0279543 (UMLS CUI [3,1])
C0005699 (UMLS CUI [3,2])
C0279543 (UMLS CUI [4,1])
C0457345 (UMLS CUI [4,2])
C0279543 (UMLS CUI [5,1])
C0457343 (UMLS CUI [5,2])
Tyrosine kinase inhibitor Investigational Chronic Myeloid Leukemia
Item
chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor.
boolean
C1268567 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0023473 (UMLS CUI [1,3])
Normal Laboratory Test Result
Item
laboratory values within normal limits.
boolean
C0438214 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decreased cardiac function
Item
impaired cardiac function.
boolean
C0232166 (UMLS CUI [1])
Liver disease Neoplasm Relationship | Kidney Disease Neoplasm Relationship | Chronic liver disease Neoplasm Relationship | Chronic Kidney Disease Neoplasm Relationship
Item
acute or chronic liver or renal disease considered unrelated to tumor.
boolean
C0023895 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0341439 (UMLS CUI [3,1])
C0027651 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C1561643 (UMLS CUI [4,1])
C0027651 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Medical condition Severe Causing Safety Risk | Medical condition Uncontrolled Causing Safety Risk | Medical condition Severe Protocol Compliance Limited | Medical condition Uncontrolled Protocol Compliance Limited | Diabetic - poor control | Communicable Diseases | Communicable Diseases Uncontrolled
Item
other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0035647 (UMLS CUI [1,5])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0036043 (UMLS CUI [2,4])
C0035647 (UMLS CUI [2,5])
C3843040 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0439801 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0439801 (UMLS CUI [4,4])
C0421258 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0009450 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Preventing Metabolism AMN107 | CYP3A4 Inhibitors | CYP3A5 Inhibitors
Item
patients who are currently receiving treatment with any of the medications that have the potential to prolong the qt interval or to inhibit the metabolism of amn107 (cyp3a4/5 inhibitors).
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C1567379 (UMLS CUI [2,4])
C3850053 (UMLS CUI [3])
C3850054 (UMLS CUI [4])
Malignant Neoplasm Clinical Significance | Malignant Neoplasm Requirement Intervention
Item
patients with a history of another malignancy that is currently clinically significant or currently requires active intervention.
boolean
C0006826 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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