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

September 22, 2015 updated by: Cephalon

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10128
        • Mount Sinai School of Medicine
      • New York City, New York, United States, 10021
        • NY Presbyterian-Cornell
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lestaurtinib
Drug: lestaurtinib
60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
Time Frame: 18 weeks +
18 weeks +

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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 +
18 weeks +

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C0701/2030/ON/US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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