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CPX-351 Liposome

Phase 1

Hematologic Neoplasms | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: May 17, 2012

Target and mechanism

ModalitySmall molecule

Also known as CPX-351 (Cytarabine:Daunorubicin) Liposome Injection

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

CPX-351 Liposome · 1 trial · 1 indication

Phase 1 1
NCT00389428Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.Hematologic Neoplasms
COMPLETED48 Analytics
PHASE1COMPLETED
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
Hematologic Neoplasms
NCT0038942848
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Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) for use in phase 2

Secondary Endpoints

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CPX-351 (Cytarabine:Daunorubicin) Liposome InjectionDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 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...

Countries:United States
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