The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.
Cohorts are dosed sequentially, and escalation may stop before the 5th cohort is dosed. Each cycle will be approximately 4 weeks in length. Following Cycle 1, patients may receive an additional 4 follow-up cycles of decitabine. Cycles 2-5 will include a 20 mg/m\^2 1-hour IV infusion of decitabine on Days 1-5 for all cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Cohort 1: 30 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
Cohort 2: 60 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
Cohort 3: 120 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
The Bronx, New York, United States
Pharmacokinetic (PK) endpoints will be decitabine PK parameters: Tmax, Cmax, AUC0-inf, t1/2 and F.
Time frame: Cycle 1 on Days 1 and 2 from predose up to 6 hours after administration.
Safety evaluations will include assessments of adverse events (AEs), medical history, physical examinations, vital signs measurements, use of concomitant medications, and laboratory assessments at baseline and throughout the study period.
Time frame: Up to 30 days after the last dose of decitabine
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cohort 4: 240 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
Unnamed facility
Houston, Texas, United States
Unnamed facility
Tacoma, Washington, United States