ID
13521
Description
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
Link
https://clinicaltrials.gov/show/NCT01361334
Keywords
Versions (6)
- 4/11/13 4/11/13 - Martin Dugas
- 7/26/13 7/26/13 - Martin Dugas
- 4/20/14 4/20/14 - Julian Varghese
- 8/18/15 8/18/15 - Martin Dugas
- 1/14/16 1/14/16 -
- 2/11/16 2/11/16 -
Uploaded on
February 11, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01361334
Eligibility Acute Myeloid Leukemia NCT01361334
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
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)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0683525
- UMLS CUI [1,2]
- C1504389
- UMLS CUI [1,3]
- C0392920
Description
2. history of cancer that according to the investigator might confound the assessment of the endpoints of the study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2735088
- UMLS CUI [1,2]
- C0006826
Description
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)
Data type
boolean
Alias
- UMLS CUI [1]
- C0030920
Description
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
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1868885
- UMLS CUI [1,2]
- C0020538
Description
5. prolongation of corrected qt interval (qtc) >480 milliseconds
Data type
boolean
Alias
- UMLS CUI [1]
- C0489625
Description
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)
Data type
boolean
Alias
- UMLS CUI [1]
- C0010068
- UMLS CUI [2]
- C0085096
- UMLS CUI [3]
- C0018802
Description
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0007785
- UMLS CUI [2]
- C2937358
- UMLS CUI [3]
- C0034065
- UMLS CUI [4]
- C0149871
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C1458140
Description
9. prior major surgery or trauma within 28 days prior to first dose of study drug
Data type
boolean
Alias
- UMLS CUI [1]
- C0679637
- UMLS CUI [2]
- C3263723
Description
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).
Data type
boolean
Alias
- UMLS CUI [1]
- C0013230
Description
11. concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0205420
Description
12. known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1831796
Description
13. patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Data type
boolean
Alias
- UMLS CUI [1]
- C0376405
Description
14. pregnant or lactating and actively breastfeeding patients
Data type
boolean
Alias
- UMLS CUI [1]
- C0549206
- UMLS CUI [2]
- C0006147
Description
15. patients taking any of the following prohibited medication: clarithromycin, telithromycin, troleandomycin (antibiotics)
Data type
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
Description
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (hiv protease inhibitors)
Data type
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
Description
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
Data type
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
Description
nefazodone (antidepressant)
Data type
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])