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RecruitingLast updated: 21 December 2021

INTEGRATE II: This phase III trial is testing the oral drug, regorafenib, for the treatment of refractory and advanced gastro-oesophageal cancersA Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Clinical summary

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-β), 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.

Conditions

This trial is treating patients with Gastro-Oesophageal Cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 75

Phase

III

Trial Acronym

INTEGRATE II

More information

Trial Identifiers

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Commercial Sponsor

Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

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

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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