Abstracts from 2008 ASCO available
Now abstracts from 2008 ASCO are available. I have copied an abstract about oral Vidaza .
"ASCO 2008 A phase I, open-label, dose-escalation study to evaluate the safety, pharmacokinetics, and pharmacodynamics of oral azacitidine in subjects with myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML)
J Clin Oncol 26: 2008 (May 20 suppl; abstr 7091)
B. S. Skikne, M. R. Ward, A. Nasser, L. Aukerman, G. Garcia-Manero
Azacitidine (Vidaza), a cytidine analog, through its effects on DNA metabolism, gene expression, and cell differentiation, has proven beneficial in treatment of MDS and AML.
Most notably, prolonged azacitidine therapy recently has been shown to approximately double 2-year survival in higher-risk MDS subjects compared to conventional care. Azacitidine is currently approved for intermittent subcutaneous and intravenous administration.
Development of an oral formulation would provide more convenient dosing, eliminate injection-site reactions, and allow evaluation of novel, continuous low-dose regimens that may sustain demethylation and improve efficacy. A proprietary formulation of oral azacitidine was shown to be absorbed in a pilot, single-dose study (ASCO 2007).
This is a multicenter, open-label, Phase 1, sequential design, dose-escalation study of oral azacitidine. The study is designed to evaluate the maximum tolerated dose, dose limiting toxicities, safety, pharmacokinetic and pharmacodynamic profiles of increasing doses of orally administered azacitidine in subjects with MDS or AML.
Azacitidine was administered subcutaneous (75 mg/m2/day x 7 days) during cycle 1, then orally starting at 120 mg x 7 days/28 day cycle. Drug levels were measured in plasma and urine, and pharmacodynamic effects including global LINE methylation and gene-specific methylation were assayed.
Currently, no toxicities have been observed in subjects who have completed both the subcutaneous and oral phases of the study at 120 mg. The study continues at the 180 mg dose level. Preliminary pharmacokinetic analysis indicates detectable plasma levels at the 120 mg oral dose.
A comparison of plasma pharmacokinetic profiles and pharmacodynamic effects of azacitidine administered at increasing oral doses compared to those of azacitidine administered subcutaneous at the approved dose of 75 mg/m2/day for all subjects evaluated to date will be presented.
Initial results of oral 5-azacitidine indicate that this formulation is orally bioavailable and safe in subjects with MDS."
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