A Phase III Study of INC424 in Polycythemia Vera Patients

• Research type

  Research Study

• Full title

  Randomized, open label, multicenter phase III study of Efficacy and Safety in POlycythemia vera subjects who are resistant to or intolerant of hydroxyurea: JAK iNhibitor INC424 tablets verSus bEst available care (The RESPONSE Trial)

• IRAS ID

  51623

• Contact name

  Harrison Claire

• Eudract number

  2010-020807-57

• ISRCTN Number

  n/a

• Research summary

  This is a Phase III.At the beginning of the study patients who have passed the screening requirements will be split into two groups and will either receive the study drug INC424 or the current best available therapy. Both the doctors and the patients will be aware of what medication they are receiving. The goal of the study is to establish if Polycythemia Vera patients benefit from treatment with INC424 compared to the current best available therapy. This will be judged by comparing both groups of patients for, the number of bleeds required to control their disease and spleen size reduction.The medicine being tested in this study is INC424 a new drug which interferes with how cancer cells divide and causes them to stop growing.INC424 is a pill which is taken twice a day.INC424 has been tested extensively in the laboratory and has been taken by more than 200 healthy subjects and 34 patients with Polycythemia Vera in an ongoing phase II trial. There are also 2 large ongoing phase III studies in myelofibrosis.Participants in the study will attend monthly clinic visits in the first 32 weeks and bi-monthly visits thereafter until the study concludes at week 80. Study procedures include MRI scan, ECG's, patient questionnaires, patient diary and blood tests.Approximately 300 patients will take part in this study around the world.This trial is sponsored by two pharmaceutical companies named Novartis and Incyte.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/93

• Date of REC Opinion

  19 Jan 2011

• REC opinion

  Further Information Favourable Opinion