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

May 16, 2012 updated by: Jazz Pharmaceuticals

Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio. The development of CPX-351 (cytarabine:daunorubicin) Liposome Injection was based on 1) defining a synergistic ratio of the two active moieties, cytarabine and daunorubicin, using cell-based screening assays and 2) designing a liposomal drug carrier to maintain this ratio after intravenous administration. CPX-351 was found to be more active in in vivo models of cancer than combinations of conventional cytarabine and daunorubicin. Both cytarabine and daunorubicin are active chemotherapeutic agents, each approved for clinical use in the United States for the treatment of hematological neoplasms.

CPX-351 is being developed with the hypothesis that it is superior to the currently used regimen of cytarabine and daunorubicin in the treatment of acute leukemia. This phase I study will determine the dose to carry forward into phase II trials.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;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:
  • The subset of RAEB-2 patients with >10% blasts with at least 1 prior therapy that includes a hypomethylating agent.
  • Previously untreated chemotherapy induced AML
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2
  • Able to adhere to the study visit schedule and other protocol requirements
  • Life expectancy of at least 12 weeks
  • Laboratory values fulfilling the following:
  • Serum creatinine < 1.5 mg/dL
  • Serum total bilirubin < 1.5 mg/dL
  • Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
  • Cardiac ejection fraction > 50% by MUGA scan or echocardiography
  • All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • Study Director: Arthur Louie, M.D., Jazz Pharmaceuticals
  • Principal Investigator: Jonathan Kolitz, M.D., New York School of Medicine at North Shore University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (ESTIMATE)

October 18, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTR0305-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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