An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation

Cephalon4 sites in 1 country39 target enrollmentDecember 2007

ConditionsPolycythemia Vera Essential Thrombocytosis

Interventionslestaurtinib

Drugslestaurtinib

Overview

Phase: Phase 2
Intervention: lestaurtinib
Conditions: Polycythemia Vera
Sponsor: Cephalon
Enrollment: 39
Locations: 4
Primary Endpoint: Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

September 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cephalon

Responsible Party

Sponsor

Eligibility 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:
•neutrophil count greater than 7000/mm3
•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).

Arms & Interventions

lestaurtinib

Intervention: lestaurtinib

Outcomes

Primary Outcomes

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

Time Frame: 18 weeks +

Secondary Outcomes

- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy(18 weeks +)