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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-75Age 18-75

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractStomach

Trial Overview Read MoreRead more

This phase III trial is testing the oral drug, regorafenib, for the treatment of refractory and advanced gastro-oesophageal cancers.
 

This trial is treating patients with Gastro-Oesophageal Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Cooperative Group

Australasian Gastro-Intestinal Trials Group (AGITG)

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.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org
0436386758

Not Recruiting Hospitals Read MoreRead more

Closed

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Ballarat Oncology & Haematology
Ballarat
Ms Rosemary Cotton
rosemaryc@ballaratoncology.com.au
03 5339 8000

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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