INTEGRATE II, an AGITG led Phase III clinical trial in gastro-oesophageal cancer has opened to recruitment. Support for the final INTEGRATE II trial design was received from Bayer in November 2015. INTEGRATE II is a Randomised Phase III Double-Blind Placebo-Controlled Study of regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) which will be conducted in Australia, New Zealand, Korea, Japan, Taiwan, Canada and the USA.
Recently, two INTEGRATE II Investigator Meetings were held, one in Sydney for Australian and New Zealand sites, and the other in Seoul for Korean, Taiwanese and Japanese sites. Delegates at these meetings included representatives from the AGITG, the NHMRC CTC, INC Research (CRO for Asia), and principal investigators and study coordinators from approximately 50 sites across the Asia-Pacific region. The intent of the meetings was to meet and build enthusiasm amongst participating sites, discuss potential regional issues affecting recruitment, and train site staff on trial procedures/processes.
Canadian and US investigator meetings are still to be determined, but will likely take place in Q1/2 2017.
The first patient on the study was recruited at Townsville Hospital, QLD in late October. Throughout the month of November, an additional 5 ANZ sites have opened and are actively looking for potential participants. 4 additional ANZ sites look likely to open in December, taking the total to 10 active ANZ sites. Korean sites are likely to begin initiations near the end of the year/early 2017, with site activations anticipated commencing in mid-January. Taiwan sites are expected to open mid — late Q1, 2017, and Japan/Canada/US sites throughout Q2.
To view Associate Professor Nick Pavlakis speaking about the INTEGRATE and INTEGRATE II trials click here