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lestaurtinib

Phase 2

Polycythemia Vera | Small molecule | Hematology |Teva Pharmaceutical Industries Limited|Last Updated: Oct 8, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00586651Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential ThrombocytosisPHASE2 COMPLETED 39Dec 1, 2007Sep 1, 2010Oct 8, 20154 United States
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Study Endpoints
Primary Endpoints
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
18 weeks +
Secondary Endpoints
- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy
18 weeks +
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
lestaurtinibEXPERIMENTAL -
Interventions
NameTypeDescription
lestaurtinibDRUG60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites4

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 * Pa...

Countries:United States
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