drugset / Trial / NCT00389428

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

NCT00389428

Phase 1 Completed 48 enrolled Jazz Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-09
Primary completion
2008-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Intravenous
Subject Daunorubicin Small molecule Intravenous