Clinical Trial: Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.

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 Summary:

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.


Sponsor: Celator Pharmaceuticals

Current Primary Outcome: To determine the maximum tolerated dose (MTD) for use in phase 2

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Celator Pharmaceuticals

Dates:
Date Received: October 16, 2006
Date Started: September 2006
Date Completion:
Last Updated: May 16, 2012
Last Verified: May 2012