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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon

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.