The ALT-GIST clinical trial, 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), has only eight patients left to randomise. This trial is the only means of accessing subsidised regorafenib in Australia at present.
Due to the prolonged start up time for the trial, there was an impact on the ongoing financial support available to conduct the trial. Therefore it was necessary to revise the recruitment target as a result of this reduced funding. After several discussions an agreement was reached to continue recruitment until 38 patients have been randomised to each trial arm resulting in a total of 76 randomised patients. A protocol amendment to reflect the revised recruitment target was recently approved in Australia. Recruitment must be completed by December 2017.
Internationally, there are 37 sites open and 68 patients randomised to the ALT-GIST trial. Seven patients were randomised in August 2017 thanks to Bankstown‐ Lidcombe Hospital (PI – Dr Ray Asghari) and St James’s University Hospital, Leeds (PI – Prof Maria Marples) on randomising their first patients!
For more information about the trial click here.