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Correction to: Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer

Authors :
Michael R. Savona
Hani M. Babiker
Dale R. Shepard
Barry S. Skikne
Maen Abdelrahim
Kao Tai Tsai
Joseph Aisner
C.L. Beach
Thai H. Ho
Mohammed M. Milhem
William Jeffery Edenfield
Eric Laille
Swaminathan P. Iyer
Source :
Cancer Chemother Pharmacol
Publication Year :
2020
Publisher :
Springer Berlin Heidelberg, 2020.

Abstract

CC-486 is an oral formulation of azacitidine that allows for extended dosing schedules to prolong azacitidine exposure to malignant cells and maximize clinical activity. CC-486 300 mg daily, administered for 14 or 21 days of 28-day treatment cycles, is currently under investigation in two ongoing phase III trials. The 300-mg daily dose in these studies is administered as two 150-mg tablets (Formulation A).We evaluated the bioequivalence of one 300-mg CC-486 tablet (Formulation B) with Formulation A and food effect on Formulation B, in adult patients with cancer in a 2-stage crossover design study.The ratios of the geometric means of the maximum azacitidine plasma concentration (CThe single 300-mg CC-486 tablet was bioequivalent to two 150-mg tablets, which have shown to be efficacious and generally well-tolerated in clinical trials, and can be taken with or without food.

Details

Language :
English
Database :
OpenAIRE
Journal :
Cancer Chemother Pharmacol
Accession number :
edsair.doi.dedup.....a194ed54d9dfa2eedb8dc8177c081158