Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.
1 other identifier
interventional
48
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2006
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2006
CompletedFirst Posted
Study publicly available on registry
October 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 17, 2012
May 1, 2012
2.3 years
October 16, 2006
May 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the maximum tolerated dose (MTD) for use in phase 2
Secondary Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Ability to understand and voluntarily sign an informed consent form
- Age \> 18 years at the time of signing the informed consent form
- Pathological confirmation of leukemia or myelodysplastic syndrome.
- AML according to WHO criteria; except for core-binding factor AMLs (t(8;21), inv(16) or t(16;16)) and APL
- ALL
- MDS
- Patients with AML include the following:
- Patients in 2nd or greater relapse
- Patients in first relapse with initial CR duration lasting \<6 months
- Patients in first relapse refractory to induction therapy
- Patients with primary refractory AML
- Patients with ALL include the following
- Patients with T-cell ALL refractory or in relapse following nelarabine
- Patients with other ALL that is refractory or in relapse.
- Patients with MDS include the following:
- +11 more criteria
You may not qualify if:
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent form
- Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry
- Clinical evidence of active CNS leukemic involvement
- Pregnant or lactating women
- Clinically significant cardiac disease (New York Heart Association Class III or IV)
- Severe debilitating pulmonary disease
- Active and uncontrolled infection. Patients with an infection under active treatment with antibiotics and whose infection is controlled may be entered into the study
- Current evidence of invasive fungal infection (blood or tissue culture); HIV or hepatitis C infection
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-related disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida
Tampa, Florida, 33612-9497, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York Presbyterian Hospital Weill Medical College of Cornell University
New York, New York, 10021, United States
Related Publications (1)
Feldman EJ, Kolitz JE, Trang JM, Liboiron BD, Swenson CE, Chiarella MT, Mayer LD, Louie AC, Lancet JE. Pharmacokinetics of CPX-351; a nano-scale liposomal fixed molar ratio formulation of cytarabine:daunorubicin, in patients with advanced leukemia. Leuk Res. 2012 Oct;36(10):1283-9. doi: 10.1016/j.leukres.2012.07.006. Epub 2012 Jul 26.
PMID: 22840315DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arthur Louie, M.D.
Jazz Pharmaceuticals
- PRINCIPAL INVESTIGATOR
Jonathan Kolitz, M.D.
New York School of Medicine at North Shore University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2006
First Posted
October 18, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
May 17, 2012
Record last verified: 2012-05