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lestaurtinib

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

lestaurtinib · 1 trial · 2 indications

Phase 2 1
NCT00586651Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential ThrombocytosisPolycythemia Vera
COMPLETED39 Analytics
PHASE2COMPLETED
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
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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 to 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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Competitive Landscape -Polycythemia Vera 11 trials

Frequently asked questions about lestaurtinib

What is lestaurtinib used for in polycythemia vera?

Lestaurtinib is an investigational small molecule being studied for the treatment of polycythemia vera, a hematologic condition. It has completed a Phase 2 clinical trial in patients with polycythemia vera or essential thrombocytosis. The drug is not approved and remains in clinical development.

What does lestaurtinib target?

Lestaurtinib is a small molecule that targets specific molecular pathways involved in hematologic malignancies. In the context of polycythemia vera, it is being evaluated for its ability to modulate disease-related signaling. The drug is administered orally and has been studied in a biomarker-selected patient population.

Who makes lestaurtinib?

Lestaurtinib is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is currently in Phase 2 clinical development for polycythemia vera and has not yet received regulatory approval.

What phase is lestaurtinib in?

Lestaurtinib is in Phase 2 clinical development for polycythemia vera. It has completed one Phase 2 trial, which was an open-label, uncontrolled study. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is lestaurtinib in?

Lestaurtinib has been studied in a completed Phase 2 clinical trial identified as NCT00586651. This open-label study enrolled 39 patients with polycythemia vera or essential thrombocytosis in the United States. The trial was uncontrolled and did not use randomization or blinding.

Is lestaurtinib the same as CEP-701?

Yes, lestaurtinib is also known as CEP-701. The clinical trial NCT00586651, which evaluated the drug in patients with polycythemia vera or essential thrombocytosis, was titled as a study of oral CEP-701 (lestaurtinib). Both names refer to the same investigational compound.