Status:
TERMINATED
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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).
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Acute Myeloid Leukemia
- Eighteen years of age or older
- Life expectancy of at least 2 months
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00279773
Start Date
September 1 2004
Last Update
June 30 2010
Active Locations (1)
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1
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77020