A Phase II clinical trial comparing Imatinib alternated with Regorafenib to Imatinib alone is currently underway and recruiting in Australia. The trial, sponsored by the Australasian Gastro-Intestinal Trials Group (http://agitg.org.au), looks to examine the feasibility of using this alternating regimen as a first line treatment for metastatic GIST patients.
This protocol, using an alternating regimen of the two drugs with brief drug free intervals, may allow tumor stem cells to re-enter the cell cycle and become susceptible once more to drug therapy.
The primary outcome measure of the study will be Progression Free Survival (PFS), with the target being 24 months.
Eligibility Requirements for the Clinical Trial
To be eligible for the trial, patients must be at least 18 years of age, have a confirmed GIST diagnosis, have unresectable, metastatic disease, and have taken no other TKIs (with the exception of up to 21 days of uninterrupted imatinib at 400 mg). Patients who were given imatinib adjuvantly are eligible provided it was completed at least three months prior to entry into the trial, but patients who progressed on adjuvant treatment are not eligible.
For more details on this clinical trial, please check http://clinicaltrials.gov and use trial identifier NCT02365441, or search the clinical trials page on the LRG website (https://liferaftgroup.org/gist-clinical-trials/) for open trials in Australia.