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

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon ) Identifier:
First received: December 21, 2007
Last updated: September 22, 2015
Last verified: September 2015
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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study. [ Time Frame: 18 weeks + ]

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 + ]

Enrollment: 39
Study Start Date: December 2007
Study Completion Date: September 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lestaurtinib 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.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00586651

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, New York
NY Presbyterian-Cornell
New York City, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10128
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cephalon Identifier: NCT00586651     History of Changes
Other Study ID Numbers: C0701/2030/ON/US
Study First Received: December 21, 2007
Last Updated: September 22, 2015

Additional relevant MeSH terms:
Polycythemia Vera
Thrombocythemia, Essential
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders processed this record on May 24, 2017