To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics and their metabolites following administration of CPX-351.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Shands Cancer Hospital @ University of Florida
Gainesville, Florida, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
John Theurer Cancer Center @ Hackensack Medical University Medical Center
Hackensack, New Jersey, United States
Total Drug Plasma PK
The following parameters will be determined:Tmax, Cmax, AUC (0-last), AUC (0-inf), AUC (0-tau), Clast/λz, λz, t1/2, Vss and CL
Time frame: Pre-dose and up to Day 21 during first induction only
Serum Copper Levels
The following parameters will be determined:Tmax, Cmax, AUC (0-last), AUC (0-inf), AUC (0-tau), Clast/λz, λz, t1/2, Vss and CL
Time frame: Pre-dose and up to Day 21 during the first induction only, prior to every course the patient receives, early termination or end of study and 60 day post end of study.
Urine Sampling
Time frame: Days 5-10 during the first induction only.
Efficacy and Safety
Time frame: Efficacy and Safety are measured up until the end of study period, SAEs are measured up to 30 days from the end of study period.
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States