Hematologic Neoplasms Clinical Trial
Official title:
Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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