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 held in Sydney for Australian and New Zealand sites, and the other held in Seoul for Korean, Taiwanese and Japanese sites.
Delegates at these Investigator 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 next year.
The first patient on the study was recruited at Townsville Hospital, QLD. Other active Australian sites include Gosford Hospital, NSW, and the Royal North Shore Hospital, NSW. Korean sites will be initiated in early December and are anticipated to open in mid-December. Both Japan and Taiwan sites will open next year.
There currently exist few effective treatment options for patients with Advanced Gastro-Oesophageal Cancer (AGOC) that has returned after surgery or where it is incurable (metastatic) at diagnosis. Chemotherapy can be effective at first, but once the cancer has become resistant to it, the options for treatment are limited. A second course of a different chemotherapy (docetaxel or irinotecan) can prolong survival, but not all patients are fit to receive this treatment. For those who do receive a second course, their cancer will eventually become resistant (or “refractory”) to these drugs. In both of these situations, there are currently no accepted treatment options that have been shown to be both effective against the cancer and tolerable for patients. Better treatment options are urgently needed.
Regorafenib (BAY 73-4506) is a ‘multi-targeted therapy’ targetting a number of different signals in the cancer cell that cause it to grow and produce blood vessels. In other cancers such as colon cancer and GIST, regorafenib has been proven to be of benefit when other drugs have ceased to work. INTEGRATE demonstrated efficacy with the use of regorafenib in AGOC, and could potentially become a new standard of care after other therapeutic agents have stopped working. INTEGRATE II is being undertaken to confirm the findings of the Phase II trial in a larger population.
If the study is positive it will provide evidence for regorafenib as a new standard of care after other treatments no longer benefit patients with gastric cancer.
“It is very exciting to be involved with such a great research team in developing and leading an international Phase II and now Phase III trial, (INTEGRATE II) for patients with advanced gastric cancer,” said Associate Professor Nick Pavlakis, Study Chair, INTEGRATE II. “We hope that at the conclusion of the INTEGRATE II trial, we will have definitive results on the use of regorafenib to extend people’s lives with this cancer.”
350 patients will be recruited from sites in Australia, New Zealand, Asia, and North America (233 to receive regorafenib; 117 to receive placebo). Half of these patients will be recruited in Asia to determine whether Asian ethnicity itself is associated with greater benefit (175 are planned to be recruited from Asia).
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