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

Sponsor

Cephalon (Industry)

Overall Status

Completed

CT.gov ID

NCT00586651

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera Essential Thrombocytosis	Drug: lestaurtinib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lestaurtinib	Drug: lestaurtinib 60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration

Arm

Intervention/Treatment

Experimental: lestaurtinib

Drug: lestaurtinib

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

Outcome Measures

Primary Outcome Measures

Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study. [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 [18 weeks +]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).
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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21231
2	NY Presbyterian-Cornell	New York City	New York	United States	10021
3	Mount Sinai School of Medicine	New York	New York	United States	10128
4	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Cephalon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cephalon

ClinicalTrials.gov Identifier:

NCT00586651

Other Study ID Numbers:

C0701/2030/ON/US

First Posted:

Jan 4, 2008

Last Update Posted:

Oct 8, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Polycythemia Vera

Polycythemia

Thrombocytosis

Thrombocythemia, Essential

Study Results

No Results Posted as of Oct 8, 2015