A Randomised Phase III Double-Blind Placebo-Controlled Study to determine if regorafenib improves overall survival in refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Trial Profile

A Randomised Phase III Double-Blind Placebo-Controlled Study to determine if regorafenib improves overall survival in refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2017

At a glance

  • Drugs Regorafenib (Primary)
  • Indications Gastric cancer; Oesophageal cancer
  • Focus Therapeutic Use
  • Acronyms INTEGRATEII
  • Most Recent Events

    • 28 Jun 2017 As of January 2017, 12 of 28 planned Australia/New Zealand sites are open, with 4 patients enrolled. Regulatory approval has been received for 12 Canadian sites, and 12 Korean sites. Korean recruitment is expected to commence in February 2017. Regulatory submissions are pending in Taiwan, Japan, and the USA.
    • 06 Jun 2017 The sample size accommodates 2 interim analyses undertaken at 1/3 and 2/3 of required events.
    • 06 Jun 2017 Trial design presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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