Vorinostat

• Research type

  Research Study

• Full title

  A Phase II Study of Vorinostat (MK-0683) In Patients With Polycythaemia Vera And Essential Thrombocythaemia

• IRAS ID

  16033

• Contact name

  MF McMullin

• Eudract number

  2007-005306-49

• Research summary

  A total of 60 patients from various countries in Europe are expected to participate in this study, including approximately up to 30 from the UK. The study will last a total of 9 months. During this period patients will attend a total of 13 visits, initially with an interval of 1 week and thereafter at 4 week intervals. In addition to routine tests patients will also have additional blood samples taken prior to and during the treatment which will be used to study exactly how Vorinostat is working and to test whether blood testing can predict how well patients are responding to the drug. 100mls of these additional blood samples will be used for purposes related to this study and a further 100mls will be frozen and stored for subsequent research analysis in a biobank. After treatment patients will continue with blood sample monitoring as usual in PV and ET. Ongoing analysis of the collected blood samples will be carried out to show whether the treatment is working effectively.

• REC name

  HSC REC A

• REC reference

  09/NIR01/63

• Date of REC Opinion

  13 Jan 2010

• REC opinion

  Further Information Favourable Opinion