The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Arm 1: Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19. Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle. Arm 2: All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.
California Cancer Care Inc
Greenbrae, California, United States
Main Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation.
Time frame: 1 - 18 months
To determine the oral bioavailability of up to 6 different oral formulations in comparison to the subcutaneous formulation
Time frame: 1 - 18 months
To assess the safety and tolerability of subcutaneous and oral formulations of azacitidine
Time frame: 1 - 18 months
To assess response rates
Time frame: 1 - 18 months
To assess RBC transfusion independence
Time frame: 1 - 18 months
To investigate the pharmacokinetics of oral azacitidine
Time frame: 1 -18 months
To assess the pharmacodynamic effects of oral azacitidine
Time frame: 1 -18 months
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University of Kansas Medical Center
Kansas City, Kansas, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northwest Cancer Specialists, P.C.
Albuquerque, New Mexico, United States
Willamette Valley Cancer Institute
Springfield, Oregon, United States
University of Texas- MD Anderson
Houston, Texas, United States
Hematology and Oncology Assoc. of South Texas
San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
...and 1 more locations