Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
The primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of antitumor activity will also be determined.
Drug: CPX-351 (Cytarabine:Daunorubicin) Liposome Injection
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.|
- To determine the maximum tolerated dose (MTD) for use in phase 2
- To evaluate the safety and dose-limiting toxicities (DLT) of CPX-351.
- To determine the pharmacokinetic parameters of CPX-351 administered in this schedule.
- To assess preliminary efficacy information of CPX-351 administered in this schedule in patients with advanced leukemias.
|Study Start Date:||September 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida|
|Tampa, Florida, United States, 33612-9497|
|United States, New York|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|New York Presbyterian Hospital Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Study Director:||Arthur Louie, M.D.||Celator Pharmaceuticals|
|Principal Investigator:||Jonathan Kolitz, M.D.||New York School of Medicine at North Shore University Hospital|