Recent Updates
Recently added Catalysts

CPX-351 Liposome

Phase 1

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

CPX-351 Liposome target and mechanism

ModalitySmall molecule

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

CPX-351 Liposome clinical trials

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 NeoplasmsUnlock trial analytics

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.
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CPX-351 (Cytarabine:Daunorubicin) Liposome InjectionDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about CPX-351 Liposome

What is CPX-351 Liposome?

CPX-351 Liposome is an investigational small molecule therapy developed for hematologic neoplasms, a group of blood cancers. It was studied in a single Phase 1 multicenter trial of 48 patients with advanced hematologic cancer in the United States. It is also known as CPX-351 (Cytarabine:Daunorubicin) Liposome Injection.

What is CPX-351 Liposome used for?

CPX-351 Liposome was studied for the treatment of hematologic neoplasms, specifically in patients with advanced hematologic cancer. The clinical program enrolled adults aged 18 years and older of any sex. The trial was conducted in the United States and has been completed.

Who makes CPX-351 Liposome?

CPX-351 Liposome is developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. Jazz Pharmaceuticals sponsored the Phase 1 multicenter study of the agent in patients with advanced hematologic cancer.

What phase is CPX-351 Liposome in?

CPX-351 Liposome is in Phase 1 clinical development. It is an investigational agent and is not described as approved. One Phase 1 trial has been completed, and no trials are currently active. That study enrolled 48 patients with advanced hematologic cancer.

What clinical trials is CPX-351 Liposome in?

CPX-351 Liposome was evaluated in the Phase 1 trial NCT00389428, titled a multicenter study of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in patients with advanced hematologic cancer. The trial enrolled 48 adults, was uncontrolled, was not randomized or double blinded, and has been completed.

Is CPX-351 Liposome the same as CPX-351 (Cytarabine:Daunorubicin) Liposome Injection?

Yes. CPX-351 Liposome and CPX-351 (Cytarabine:Daunorubicin) Liposome Injection refer to the same investigational agent. The full name describes the liposomal formulation containing cytarabine and daunorubicin. Both names appear in the Phase 1 trial record NCT00389428 in advanced hematologic cancer.