CAMN107DDE05

• Research type

  Research Study

• Full title

  An open-label, multi-centre study to evaluate the efficacy of nilotinib in adult patients with gastrointestinal stromal tumours resistant to imatinib and sunitinib

• IRAS ID

  28575

• Contact name

  Michael Leahy

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2008-000357-35

• Research summary

  This is an open - label (which means that everyone participating will receive the study medication, nilotinib), multi-centre, single-arm (everyone has the same treatment for the time they are in the trial) phase III trial, to show if nilotinib has an effect in adult patients with unresectable or metastatic gastrointestinal stromal tumours showing progression of disease whilst being treated with imatinib and/or sunitinib or if the side effects of imatinib and/or sunitinib are too much.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/134

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion