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

Phase 1 Terminated 34 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2004-09
Primary completion: 2007-10
Completion: —

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dovitinib	Small molecule	—	Oral

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

Summary

Timeline

Publications

Drugs

Indications