Spots Global Cancer Trial Database for Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
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Trial Identification
Brief Title: Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
Official Title: Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.
Study ID: NCT00389428
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgetown University Medical Center, Washington, District of Columbia, United States
H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida, Tampa, Florida, United States
North Shore University Hospital, Manhasset, New York, United States
New York Presbyterian Hospital Weill Medical College of Cornell University, New York, New York, United States
Contact Details
Name: Arthur Louie, M.D.
Affiliation: Jazz Pharmaceuticals
Role: STUDY_DIRECTOR
Name: Jonathan Kolitz, M.D.
Affiliation: New York School of Medicine at North Shore University Hospital
Role: PRINCIPAL_INVESTIGATOR
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