Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
NCT ID: NCT00279773
Last Updated: 2010-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
34 participants
INTERVENTIONAL
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TKI258 - dose escalation
Dose-Escalation
TKI258
TKI258 - dose expansion
Dose-Expansion
TKI258
Interventions
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TKI258
Eligibility Criteria
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Inclusion Criteria
* Eighteen years of age or older
* Life expectancy of at least 2 months
Exclusion Criteria
* Clinically significant cardiac disease
* Diabetes mellitus uncontrolled with medication
* Pregnant or breast feeding women
* Dementia or altered mental status
* Known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands
* Previous pericarditis
* Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24.
Other Identifiers
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CTKI258A2102
Identifier Type: -
Identifier Source: org_study_id