NCT00866762

A Study of the Efficacy of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia

A Phase II Study of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2 V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2 allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and endothelial activation , which are considered to be major determinants of morbidity and mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused gene expression profiling, epigenome profiling and proteomics.

Conditions

• Polycythemia Vera
• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	HDAC inhibitor (MK-0683)	400 mg once daily for 6 months

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2009-03-20
• Last updated: 2011-12-12

Locations

16 sites across 4 countries: Denmark, Netherlands, Sweden, United Kingdom