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

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Contents

clinicaltrials.gov/study/NCT00389428
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT003894280
Trial Recruitment Size
480
Trial Sponsor
Jazz Pharmaceuticals
Jazz Pharmaceuticals
0
Clinical Trial Start Date
2006
0
Primary Completion Date
2008
0
Study Completion Date
2009
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 10
Participating Facility
Georgetown University Medical Center
Georgetown University Medical Center
0
North Shore University Hospital
North Shore University Hospital
0
Official Name
Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies0
Last Updated
May 17, 2012
0
Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.

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