Imatinib and BYL719 in patients with Gastrointestinal Stromal Tumour.

• Research type

  Research Study

• Full title

  A dose-finding phase Ib multicenter study of imatinib in combination with the oral phosphatidyl-inositol 3-kinase (PI3K) inhibitor BYL719 in patients with gastrointestinal stromal tumor (GIST) who failed prior therapy with imatinib and sunitinib.

• IRAS ID

  116861

• Contact name

  Daniel Stark

• Contact email

  d.p.stark@leeds.ac.uk

• Sponsor organisation

  Novartis Pharma Services AG.

• Eudract number

  2012-003273-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a dose finding study in which safety and tolerability of escalating doses of new drug called BYL719 in combination with a standard treatment in this disease, imatinib 400 mg in patients with metastatic and/or unresectable gastrointestinal stromal tumor (GIST), who have failed prior therapy with imatinib and sunitinib.
  The study is in 2 parts. The first part of the study is the dose escalation phase and its purpose is to find what dose of BYL719 can be given safely in combination with Imatinib. The second part of the study is called the dose expansion phase and its purpose is to find out if the combination of Imatinib and BYL719 is effective in controlling the cancer. STI571 (Imatinib) and BYL719 are drugs manufactured and developed by Novartis Pharmaceuticals. There is evidence from current state-of-the art biological science about GIST that that when used together, Imatinib and BYL719 will be able to keep the GIST under control.

  Patients will continue to receive treatment until their disease progresses (worsens), or they have unacceptable side effects.

  About 45-55 patients will join in this study at centers in several countries in Europe, the USA and South Korea.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  13/WM/0318

• Date of REC Opinion

  4 Sep 2013

• REC opinion

  Favourable Opinion