Imatinib with BKM120 in patients with Gastrointestinal Stromal Tumour

• Research type

  Research Study

• Full title

  A multi-arm dose-finding phase Ib multicenter study of imatinib in combination with the oral phosphatidyl-inositol 3-kinase (PI3-K) inhibitor BKM120 in patients with Gastrointestinal Stromal Tumor (GIST) who failed prior therapy with imatinib and sunitinib.

• IRAS ID

  98000

• Contact name

  Michael Leahy

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-002938-39

• ISRCTN Number

  not issued

• Research summary

  This study is a multi-arm, open-label, phase Ib, dose-finding study in which the safety and tolerability of escalating doses of BKM120 in combination with imatinib in patients with Gastrointestinal Stromal Tumour( GIST), in patients who have failed prior therapy with imatinib and sunitinib will be investigated . There will be two parts to the study 1) a dose escalation part to establish the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) and 2) a dose expansion part at the MTD or RP2D. It is expected to recruit 45-55 patients in this study.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/0446

• Date of REC Opinion

  11 Jun 2012

• REC opinion

  Further Information Favourable Opinion