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CompletedNCT00586651Updated Oct 8, 2015

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

A Phase 2 interventional study of lestaurtinib in Polycythemia Vera and Essential Thrombocytosis, sponsored by Cephalon. Completed at 4 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-10-08.

Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Polycythemia Vera
  • Essential Thrombocytosis
03

In context

Polycythemia Vera

238 studies on the registry are indexed under Polycythemia Vera; 57 are open to participants now.

This study's enrollment of 39 is below the median of 55 across 180 interventional studies indexed under Polycythemia Vera.

Browse Polycythemia Vera studies →

Lead sponsor

Cephalon is the lead sponsor of 75 studies on the registry; none are open to participants now.

First submitted before Cephalon became part of Teva Pharmaceutical Industries, Ltd..

Browse Cephalon studies →All Teva Pharmaceutical Industries, Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    lestaurtinib

    Drug: lestaurtinib

Interventions

  • Druglestaurtinib

    60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration

06

What researchers measure

Primary outcomes

  1. Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.

    Time frame: 18 weeks +

Secondary outcomes

  1. - 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 +

07

Study locations

4 sites
  • Johns Hopkins University
    Baltimore, Maryland 21231, United States
  • NY Presbyterian-Cornell
    New York, New York 10021, United States
  • Mount Sinai School of Medicine
    New York, New York 10128, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Publications

  • Hexner E, Roboz G, Hoffman R, Luger S, Mascarenhas J, Carroll M, Clementi R, Bensen-Kennedy D, Moliterno A. Open-label study of oral CEP-701 (lestaurtinib) in patients with polycythaemia vera or essential thrombocythaemia with JAK2-V617F mutation. Br J Haematol. 2014 Jan;164(1):83-93. doi: 10.1111/bjh.12607. Epub 2013 Oct 28. PubMed 24903629 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00586651
Lead sponsor
Cephalon
Responsible party
Sponsor
First posted
Jan 4, 2008
Start date
Dec 2007
Primary completion
Oct 2009
Completion
Sep 2010
Last update
Oct 8, 2015
View the source record on ClinicalTrials.gov ↗

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