Study endpoints
death, tumourigenesis, gastric cancer, tumour, Cancer
ADVERSE EVENTS, CANCER, TUMOUR, GASTRIC CANCER
The primary end point for INTEGRATE IIa and INTEGRATE IIb is overall survival in each arm, defined as the interval from date of randomisation to date of death from any cause or the date the patient was last known to be alive. Secondary objectives for INTEGRATE IIa and INTEGRATE IIb are PFS, ORR (according to RECIST v1.1), QOL and safety profile (rates of adverse events per CTCAE v4.03). The tertiary and correlative endpoints may include: investigation of VEGF-related biomarkers and biomarkers relating to angiogenesis and/or tumourigenesis in blood and tumour as prognostic and/or predictive markers for study endpoints relating to survival, response and safety; regorafenib levels to evaluate pharmacokinetics in participants from different geographical regions; evaluation of the prevalence and distribution of the four proposed molecular phenotypes of gastric cancer proposed by the Cancer Genome Atlas Research Network [