Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs
cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar
ratio. The development of CPX-351 (cytarabine:daunorubicin) Liposome Injection was based on
1) defining a synergistic ratio of the two active moieties, cytarabine and daunorubicin,
using cell-based screening assays and 2) designing a liposomal drug carrier to maintain this
ratio after intravenous administration. CPX-351 was found to be more active in in vivo
models of cancer than combinations of conventional cytarabine and daunorubicin. Both
cytarabine and daunorubicin are active chemotherapeutic agents, each approved for clinical
use in the United States for the treatment of hematological neoplasms.
CPX-351 is being developed with the hypothesis that it is superior to the currently used
regimen of cytarabine and daunorubicin in the treatment of acute leukemia. This phase I
study will determine the dose to carry forward into phase II trials.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) for use in phase 2
Arthur Louie, M.D.
United States: Food and Drug Administration
|North Shore University Hospital||Manhasset, New York 11030|
|Georgetown University Medical Center||Washington, District of Columbia 20007|
|H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida||Tampa, Florida 33612-9497|
|New York Presbyterian Hospital Weill Medical College of Cornell University||New York, New York 10021|