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

Completed · Phase 2

Conditions studied: Polycythemia Vera, Essential Thrombocytosis

In brief

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).

Key facts

Study ID

NCT00586651

Run by

Cephalon

People needed

39

Starts

2007-12-01

Expected to finish

2010-09-01

Last updated by the study team

2015-10-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• NY Presbyterian-Cornell — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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