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Friday, June 04, 2010 6:20:27 AM

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ASCO Trials in Progress Poster Session 06/07,2010

Session: Trials in Progress Poster Session

Type: Trials in Progress Poster Session

Time: Monday June 7, 8:00 AM to 12:00 PM

Location: S Hall A2

http://www.asco.org/portal/site/ascov2/gsasearch?q=AS1413&x=31&y=5


A phase IIa pharmacokinetic and efficacy study of amonafide (AS1413) in combination with cytarabine in patients with acute myeloid leukemia.

Sub-category: Leukemia

Category: Leukemia, Myelodysplasia, and Transplantation

Meeting: 2010 ASCO Annual Meeting

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS278)

Abstract No: TPS278

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Session: Trials in Progress Poster Session

Type: Trials in Progress Poster Session

Time: Monday June 7, 8:00 AM to 12:00 PM

Location: S Hall A2
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Author(s): A. S. Lundberg, S. L. Allen, AS1413-101 Investigator Group; Antisoma, Cambridge, MA; North Shore Long Island Jewish Health System, Manhasset, NY

Abstract:

Background: Amonafide is a novel DNA intercalator that is not affected by multidrug resistance mechanisms, a common cause of treatment failure in AML. Amonafide has previously been studied in combination with cytarabine in patients with secondary AML in a phase I dose- escalation study and a phase II safety and efficacy study. The phase III ACCEDE study is comparing amonafide + cytarabine to daunorubicin + cytarabine in previously untreated secondary AML (sAML). The pharmacokinetics (PK) of amonafide when given at lower doses and as monotherapy has been extensively studied. This study is designed to further determine the amonafide PK in the combination antileukemic regimen being evaluated clinically and to facilitate the development of a population PK model for further clinical studies. Methods: This is a multicenter, single-arm, fixed-dose phase IIa study of amonafide + cytarabine in with newly diagnosed, relapsed, or refractory adult patients with AML. The objectives of the study are to define the plasma PK profile and urinary excretion of amonafide and metabolite(s) and to evaluate the safety, tolerability, and remission rate of amonafide in combination with cytarabine. Patients will receive therapy with amonafide 600 mg/m2/day IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV CI daily on days 1-7, with a second course for persistent leukemia on day 14. Up to 30 patients are expected to be enrolled and treated in this study.
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