Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).

Key facts

Study ID

NCT00279773

Run by

Novartis Pharmaceuticals

People needed

34

Starts

2004-09-01

Last updated by the study team

2010-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Acute Myeloid Leukemia
• Eighteen years of age or older
• Life expectancy of at least 2 months

You may not qualify if…

• Intracranial disease or epidural disease
• 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

Where it is running

• The University of Texas, M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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