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

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00586651

Purpose

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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:

Genetics Home Reference related topics: hemophilia

Drug Information available for: CEP 701

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

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 ]

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 + ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586651

Locations

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

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon Oncology ( Sponsor's Medical Expert )
Study ID Numbers:	C0701/2030/ON/US
Study First Received:	December 21, 2007
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00586651 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Polycythemia Vera
Polycythemia
Hemorrhagic Disorders
Hematologic Diseases
Blood Platelet Disorders

Blood Coagulation Disorders
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 05, 2009