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Blood, 15 May 2004, Vol. 103, No. 10, pp. 3669-3676. Prepublished online as a Blood First Edition Paper on January 15, 2004; DOI 10.1182/blood-2003-11-3775. This Article Full Text (PDF) All Versions of this Article: 2003-11-3775v1 103/10/3669    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Smith, B D Articles by Small, D. Search for Related Content PubMed PubMed Citation Articles by Smith, B D Articles by Small, D. Related Collections Related Article in Blood Online Social Bookmarking                   What's this? Submitted November 5, 2003 Accepted January 4, 2004 Single agent CEP-701, a novel FLT3 inhibitor, shows biologic and clinical activity in patients with relapsed or refractory acute myeloid leukemia B D Smith*, Mark Levis, Miloslav Beran, Francis Giles, Hagop Kantarjian, Karin Berg, Kathleen Murphy, Tianna Dauses, Jeffrey Allebach, and Donald Small Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA Oncology, MD Anderson Cancer Center, Houston, TX, USA * Corresponding author; email: smithdo{at}jhmi.edu. Activating mutations of FLT3 are present in approximately 30% of de novo AML and are associated with lower cure rates to standard chemotherapy-based treatment. Targeting the mutation by inhibiting the tyrosine kinase activity of FLT3 is cytotoxic to cell lines and primary AML cells harboring FLT3 mutations. Successful FLT3 inhibition can also improve survival in mouse models of FLT3-activated leukemia. CEP-701 is an orally-available, novel receptor tyrosine kinase inhibitor that selectively inhibits FLT3 autophosphorylation. We undertook a phase I/II trial to determine the in vivo hematologic effects of single-agent CEP-701 as salvage treatment for patients with refractory, relapsed or poor risk AML expressing FLT3-activating mutations. Fourteen heavily pretreated AML patients were treated with CEP-701 at an initial dose of 60 mg orally twice daily. CEP-701 related toxicities were minimal. Five patients had clinical evidence of biologic activity and a measurable clinical response, including significant reductions in both bone marrow and peripheral blood blasts. Laboratory data confirmed that clinical responses correlated with sustained FLT3 inhibition to CEP-701. Our results show that FLT3 inhibition is associated with clinical activity in AML patients harboring FLT3 activating mutations and indicate that CEP-701 holds promise as a novel, molecularly targeted therapy in this disease. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: Pharmacodynamics provide critical insight in drug development Michael Grever Blood 2004 103: 3614. [Full Text] [PDF] This article has been cited by other articles: C. J. Thiele, Z. Li, and A. E. McKee On Trk--The TrkB Signal Transduction Pathway Is an Increasingly Important Target in Cancer Biology Clin. Cancer Res., October 1, 2009; 15(19): 5962 - 5967. [Abstract] [Full Text] [PDF] P. P. Zarrinkar, R. N. Gunawardane, M. D. Cramer, M. F. Gardner, D. Brigham, B. Belli, M. W. Karaman, K. W. Pratz, G. Pallares, Q. Chao, et al. 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