Last updated on September 2017

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

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Brief description of study

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

Detailed Study Description

Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no established standard treatment following failure of first and second line chemotherapy. Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-ß), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases, and has shown activity in other solid tumours. Regorafenib was shown to prolong PFS across all regions/subgroups in INTEGRATE I The general aim of this study is to determine if regorafenib improves overall survival in refractory AGOC.