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Sponsored by: |
Celator Pharmaceuticals |
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Information provided by: | Celator Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00389428 |
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.
Condition | Intervention | Phase |
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Hematologic Neoplasms |
Drug: CPX-351 (Cytarabine:Daunorubicin) Liposome Injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies. |
Estimated Enrollment: | 36 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Celator Pharmaceuticals ( Michael Chiarella Director Clinical Operations ) |
Study ID Numbers: | CLTR0305-101 |
Study First Received: | October 16, 2006 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00389428 |
Health Authority: | United States: Food and Drug Administration |
Hematologic malignancies Malignancies, hematologic Hematopoietic malignancies |
Daunorubicin Hematologic Neoplasms Hematologic Diseases Cytarabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |