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Brief Title: A Study of the Efficacy of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia
Official Title: A Phase II Study of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia.
Study ID: NCT00866762
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Copenhagen University Hospital Rigshospitalet, Copenhagen, , Denmark
Esberg Hospital, Esbjerg, , Denmark
Herlev Hospital, Herlev, , Denmark
Odense University Hospital, Odense, , Denmark
Roskilde Hospital, Roskilde, , Denmark
Regional Hospital Viborg, Viborg, , Denmark
VU University Medical Centre, Amsterdam, , Netherlands
University Hospital Orebro, Orebro, , Sweden
Stockholm South General Hospital (Sodersjukhuset), Stockholm, , Sweden
Karolinska University Hospital Huddinge, Stockholm, , Sweden
Sahlgrenska University Hospital & Uddevalla Hospital, Uddevalla, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom
Cardiff University, Cardiff, , United Kingdom
Russell's Hall Hospital, Dudley, , United Kingdom
St Thomas' Hospital, London, , United Kingdom
Name: Hans C Hasselbalch, MD
Affiliation: Department of Hematology, Copenhagen University Hospital Herlev
Role: PRINCIPAL_INVESTIGATOR