Acute Myeloid Leukemia Clinical Trial

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

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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).

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Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT00279773

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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The University of Texas, M.D. Anderson Cancer Center
Houston Texas, 77020, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT00279773

Recruitment Status:

Terminated

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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