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  • AG0315OG /CTC0140

    Acronym: 

    AG0315OG

    ACTRN/NCT /ethics: 

    NCT02773524

    Scientific title: 

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

    Summary of trial and patient characteristics

    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase III Tumour Stream Gastro- Oesophageal
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2016-06-01
    Molecular Target Anticipated End Date 2019-04-01
    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Gastro- Oesophageal
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2016-06-01
    Anticipated End Date 2019-04-01

    Trial Summary

    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-?), 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.

    Lay Summary

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

    Sponsor / Cooperative group

    Australasian Gastro-Intestinal Trials Group (AGITG Integrate)

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting