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Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis

This study is currently recruiting participants.
Verified by Cephalon, June 2008

Sponsored by: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00586651
  Purpose

This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).


Condition Intervention Phase
Polycythemia Vera
Essential Thrombocytosis
Drug: lestaurtinib
Phase II

Genetics Home Reference related topics:   hemophilia   

ChemIDplus related topics:   CEP 701   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:   An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation

Further study details as provided by Cephalon:

Primary Outcome Measures:
  • Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study. [ Time Frame: 18 weeks + ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy [ Time Frame: 18 weeks + ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   December 2007
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: lestaurtinib
    60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
Detailed Description:

This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • The patient has polycythemia vera (PV) or essential thrombocytosis (ET).
  • The patient has a detectable JAK2 V617F mutation.
  • Patients with PV have at least 1 of the following risk factors:

    1. neutrophil count greater than 7000/mm3
    2. receiving hydroxyurea treatment
  • Patients with ET are receiving concomitant hydroxyurea.
  • The patient has an ECOG performance score of 0, 1, or 2.

Exclusion Criteria:

  • The patient has bilirubin levels or aspartate transaminases (AST) levels within exclusionary ranges.
  • patient has serum creatinine concentrations within exclusionary ranges.
  • patient has an untreated or progressive infection.
  • patient has any physical or psychiatric condition that may compromise participation in the study.
  • has a history of venous or arterial thrombosis within 6 months.
  • use of hydroxyurea has been initiated or escalated in the month prior to screening.
  • has active gastrointestinal ulceration or bleeding.
  • patient has used an investigational drug within the past 30 days.
  • patient is being treated with anagrelide.
  • patient has previously taken CEP-701 (lestaurtinib).
  • patient has hypersensitivity to CEP-701 (lestaurtinib) or any component of CEP-701 (lestaurtinib).
  • patient has received interferon within the past 30 days.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586651

Contacts
Contact: Cephalon Contact     1-800-283-4396    

Locations
United States, Maryland
Johns Hopkins University     Recruiting
      Baltimore, Maryland, United States, 21231
      Contact: Cedron Williams            
      Principal Investigator: Alison Moliterno, MD            
United States, New York
NY Presbyterian-Cornell     Recruiting
      New York City, New York, United States, 10021
      Contact: Diane Lancaster, RN            
      Principal Investigator: Gail Roboz, MD            
United States, Pennsylvania
University of Pennsylvania     Recruiting
      Philadelphia, Pennsylvania, United States, 19104
      Principal Investigator: Selina Luger, MD            

Sponsors and Collaborators
Cephalon
  More Information


Responsible Party:   Cephalon Oncology ( Sponsor's Medical Expert )
Study ID Numbers:   C0701/2030/ON/US
First Received:   December 21, 2007
Last Updated:   June 24, 2008
ClinicalTrials.gov Identifier:   NCT00586651
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Polycythemia
Polycythemia Vera
Essential thrombocytosis
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Myeloproliferative Disorders
Polycythemia vera
Hemostatic Disorders
Thrombocytopathy
Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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