ID
13521
Beskrivning
Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible; ODM derived from: https://clinicaltrials.gov/show/NCT01361334 Principal Investigator: PD Dr. Torsten Kessler, University Hospital Muenster, Germany
Länk
https://clinicaltrials.gov/show/NCT01361334
Nyckelord
Versioner (6)
- 2013-04-11 2013-04-11 - Martin Dugas
- 2013-07-26 2013-07-26 - Martin Dugas
- 2014-04-20 2014-04-20 - Julian Varghese
- 2015-08-18 2015-08-18 - Martin Dugas
- 2016-01-14 2016-01-14 -
- 2016-02-11 2016-02-11 -
Uppladdad den
11 februari 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01361334
Eligibility Acute Myeloid Leukemia NCT01361334
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
1. patients with a valid option for intensive chemotherapy and/or stem cell transplantation (patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and graft-versus host disease must have resolved to grade ≤2)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0683525
- UMLS CUI [1,2]
- C1504389
- UMLS CUI [1,3]
- C0392920
Beskrivning
2. history of cancer that according to the investigator might confound the assessment of the endpoints of the study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2735088
- UMLS CUI [1,2]
- C0006826
Beskrivning
3. uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030920
Beskrivning
4. poorly controlled hypertension [defined as systolic blood pressure (sbp) of ≥140 mmhg or diastolic blood pressure (dbp) of ≥90 mmhg]. note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. bp must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) sbp / dbp values from each bp assessment must be <140/90 mmhg in order for a subject to be eligible for the study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1868885
- UMLS CUI [1,2]
- C0020538
Beskrivning
5. prolongation of corrected qt interval (qtc) >480 milliseconds
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
6. history of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class iii or iv congestive heart failure, as defined by the new york heart association (nyha)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0010068
- UMLS CUI [2]
- C0085096
- UMLS CUI [3]
- C0018802
Beskrivning
7. history of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (dvt) within the past 6 months. note: subjects with recent dvt who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0007785
- UMLS CUI [2]
- C2937358
- UMLS CUI [3]
- C0034065
- UMLS CUI [4]
- C0149871
Beskrivning
8. evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to aml-related thrombocytopenia which will be treated using platelet transfusions). also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1458140
Beskrivning
9. prior major surgery or trauma within 28 days prior to first dose of study drug
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0679637
- UMLS CUI [2]
- C3263723
Beskrivning
10. treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013230
Beskrivning
11. concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0205420
Beskrivning
12. known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1831796
Beskrivning
13. patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0376405
Beskrivning
14. pregnant or lactating and actively breastfeeding patients
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0549206
- UMLS CUI [2]
- C0006147
Beskrivning
15. patients taking any of the following prohibited medication: clarithromycin, telithromycin, troleandomycin (antibiotics)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0683610
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0055856
- UMLS CUI [1,4]
- C0907410
- UMLS CUI [1,5]
- C0041165
Beskrivning
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (hiv protease inhibitors)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0683610
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0754188
- UMLS CUI [2]
- C0525005
- UMLS CUI [3]
- C0286738
- UMLS CUI [4]
- C0292818
Beskrivning
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0683610
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0022625
- UMLS CUI [2]
- C0064113
- UMLS CUI [3]
- C0016277
Beskrivning
nefazodone (antidepressant)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0683610
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0068485
Similar models
Eligibility Acute Myeloid Leukemia NCT01361334
- StudyEvent: Eligibility
C0205269 (UMLS CUI [1,2])
C0278780 (UMLS CUI [1,3])
C1554961 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C1982687 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C2937358 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0149871 (UMLS CUI [4])
C3263723 (UMLS CUI [2])
C0205420 (UMLS CUI [1,2])
C1831796 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0055856 (UMLS CUI [1,3])
C0907410 (UMLS CUI [1,4])
C0041165 (UMLS CUI [1,5])
C0013227 (UMLS CUI [1,2])
C0754188 (UMLS CUI [1,3])
C0525005 (UMLS CUI [2])
C0286738 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0013227 (UMLS CUI [1,2])
C0022625 (UMLS CUI [1,3])
C0064113 (UMLS CUI [2])
C0016277 (UMLS CUI [3])
C0013227 (UMLS CUI [1,2])
C0068485 (UMLS CUI [1,3])