This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
University of Kansas Cancer Center
Pharmacokinetics (PK) of CPX-351
The key PK parameter AUCtau will be assessed
Time frame: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
PK parameter of the individual components of CPX-351, and their respective metabolites
The key PK parameter AUCtau will be assessed
Time frame: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
Incidence of Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as any AE starting after the initiation of the first infusion.
Time frame: Up to 31 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Westwood, Kansas, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
New York Medical/Westchester
Valhalla, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Baylor University Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
...and 3 more locations