NCT00586651

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2007

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 8, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

December 21, 2007

Last Update Submit

September 22, 2015

Conditions

Polycythemia VeraEssential Thrombocytosis

Outcome Measures

Primary Outcomes (1)

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

    18 weeks +

Secondary Outcomes (1)

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

    18 weeks +

Study Arms (1)

lestaurtinib

EXPERIMENTAL
Drug: lestaurtinib

Interventions

lestaurtinibDRUG

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

lestaurtinib

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

NY Presbyterian-Cornell

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10128, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 24903629DERIVED

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, Essential

Interventions

lestaurtinib

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2009

Study Completion

September 1, 2010

Last Updated

October 8, 2015

Record last verified: 2015-09

Locations

US(4)