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

Tracking Information
First Received Date ^ICMJE	December 21, 2007
Last Updated Date	July 15, 2009
Start Date ^ICMJE	December 2007
Estimated Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2007)	Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study. [ Time Frame: 18 weeks + ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00586651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2007)	- 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 + ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
Official Title ^ICMJE	An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Single Group Assignment
Condition ^ICMJE	Polycythemia Vera Essential Thrombocytosis
Intervention ^ICMJE	Drug: lestaurtinib
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	39
Estimated Completion Date	November 2010
Estimated Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00586651
Responsible Party	Sponsor's Medical Expert, Cephalon Oncology
Study ID Numbers ^ICMJE	C0701/2030/ON/US
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cephalon
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP