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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Polycythemia Vera Essential Thrombocytosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lestaurtinib

Group Type EXPERIMENTAL

lestaurtinib

Intervention Type DRUG

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

Interventions

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lestaurtinib

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No