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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00586651
First received: December 21, 2007
Last updated: August 22, 2013
Last verified: August 2013

December 21, 2007
August 22, 2013
December 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00586651 on ClinicalTrials.gov Archive Site
- 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 ]
Same as current
Not Provided
Not Provided
 
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation

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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycythemia Vera
  • Essential Thrombocytosis
Drug: lestaurtinib
60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
Experimental: lestaurtinib
Intervention: Drug: lestaurtinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
September 2010
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586651
C0701/2030/ON/US
Not Provided
Teva Pharmaceutical Industries ( Cephalon )
Cephalon
Not Provided
Not Provided
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP