Protocol Title: A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST)
Study Chair: A/Prof Desmond Yip (The Canberra Hospital, Woden ACT)
Program Manager: Cheryl Friend
Trial Coordinator: Jenna Mitchell
Detailed information available on the Australian and New Zealand Clinical Trials Registry — ALT GIST
Aim: The general aim of the ALT GIST Study is to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety to warrant further evaluation as a first line treatment for metastatic GIST.
Background: Despite highly active current treatment for metastatic gastrointestinal stromal tumour (GIST) with the use of imatinib, most people will ultimately relapse and die of multifocal metastatic disease. Using an alternating regimen of imatinib and regorafenib with brief drug free intervals may allow tumour stem cells to re-enter the cell cycle and become susceptible once more to drug therapy. Regorafenib, a multi-targeted tyrosine kinase inhibitor (TKI) with activity against angiogenic, stromal and oncogenic receptor tyrosine kinases, has demonstrated activity in the treatment of GIST and is FDA approved for third line therapy of advanced GIST.
Study Design: Prospective, randomised, open label phase II trial, with randomisation 1:1 and stratification by site, receipt of previous adjuvant therapy (prior vs none), and receipt of imatinib for metastatic disease for less than 21 days.
Objectives: The primary objective for the study is progression free survival at 24 months while secondary objectives include objective tumour response rate, clinical benefit rate, complete response rate, time-to-treatment failure, safety/toxicity/tolerability and overall survival.
To view ALT GIST Schema click here.