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

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.