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

Primary Purpose

Polycythemia Vera, Essential Thrombocytosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

lestaurtinib

About this trial

This is an interventional treatment trial for Polycythemia Vera

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins University
NY Presbyterian-Cornell
Mount Sinai School of Medicine
University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lestaurtinib

Arm Description

Outcomes

Primary Outcome Measures

Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.

Secondary Outcome Measures

- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy

Full Information

NCT ID

NCT00586651

First Posted

December 21, 2007

Last Updated

September 22, 2015

Sponsor

Cephalon

1. Study Identification

Unique Protocol Identification Number

NCT00586651

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cephalon

4. Oversight

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycythemia Vera, Essential Thrombocytosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lestaurtinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

lestaurtinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.

Time Frame

18 weeks +

Secondary Outcome Measure Information:

Title

- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy

Time Frame

18 weeks +

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

NY Presbyterian-Cornell

City

New York City

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24903629

Citation

Hexner E, Roboz G, Hoffman R, Luger S, Mascarenhas J, Carroll M, Clementi R, Bensen-Kennedy D, Moliterno A. Open-label study of oral CEP-701 (lestaurtinib) in patients with polycythaemia vera or essential thrombocythaemia with JAK2-V617F mutation. Br J Haematol. 2014 Jan;164(1):83-93. doi: 10.1111/bjh.12607. Epub 2013 Oct 28.

Results Reference

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

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