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

A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia

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).

Inclusion Criteria:

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

Exclusion Criteria:

• 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