INTEGRATE IIa: A Randomised Phase III Double-Blind Placebo-Controlled Study of regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Refractory AGOC has limited options. Five-year survival for AGOC is <7% and, medium overall survival remains less than 1 year. Regorafenib is an oral multi-kinase inhibitor with a distinct profile, targeting angiogenic, stromal and oncogenic receptor tyrosine kinases.

INTEGRATE IIa was a double-blind placebo-controlled phase 3 trial comparing regorafenib and best supportive care (BSC) vs placebo and BSC for subjects with confirmed evaluable metastatic/locally advanced AGOC on a 2:1 randomisation, stratified by tumour location, geographic region (Asia vs rest of world), prior VEGF inhibitors, in patients who failed ≥ 2 prior therapies.