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

Polycythemia Vera Clinical Trial

Official title:

An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586651
• Other study ID #: C0701/2030/ON/US
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: September 22, 2015
• Start date: December 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Thrombocytosis
• Polycythemia
• Polycythemia Vera
• Thrombocythemia, Essential
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• lestaurtinib
60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Mount Sinai School of Medicine	New York	New York
United States	NY Presbyterian-Cornell	New York City	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.		18 weeks +	No
Secondary	- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy		18 weeks +	No