INTEGRATE

A Randomised Phase II Double-Blind Placebo-Controlled Study of regorafenib in Refractory Advanced Oesophago-Gastric Cancer (AOGC).

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Trial Status

Completed

Cancer Type

Oesophageal Cancer

Aim

The purpose of the INTEGRATE study is to investigate if a new drug, regorafenib, is a safe and active treatment for people with stomach cancer who have progressed after treatment with standard chemotherapy.

Summary

The trial was part of the search for better treatments for cancer of the lower oesophagus and stomach. Regorafenib (Stivarga) is a new biological treatment that was already in use to act against the growth of colon tumours and GISTs (gastrointestinal stromal tumours). INTEGRATE tested the effect on stomach tumours. The trial was a phase 2 trial, a small trial designed to test the drug’s safety and effect on the tumour. We recruited 152 patients from Australia, New Zealand, Korea and Canada. Patients were randomly allocated to regorafenib or a placebo tablet. The randomisation system was set up to allocate two‐thirds of patients to the trial drug and one‐third to placebo. Four out of five patients were men. All patients had advanced disease that had come back after chemotherapy. They took the tablets for 21 days in each month. Whether patients were on the new drug or the placebo, they all had the usual supportive care by their oncologists and other health professionals.

Trial Status

Completed

Cancer Type

Oesophageal Cancer

Publication Reference

Pavlakis N, Sjoquist KM, Martin AJ, Tsobanis E, Yip S, Kang YK, Bang YJ, Alcindor T, O’Callaghan CJ, Burnell MJ, Tebbutt NC, Rha SY, Lee J, Cho JY, Lipton LR, Wong M, Strickland A, Kim JW, Zalcberg JR, Simes J, Goldstein D. Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): a multinational placebo-controlled phase II trial. Journal of Clinical Oncology 2016; 34(23): 2728-2735.

Conference Presentation Reference

  1. Yip S, Harvie R, Martin AJ, Sjoquist KM, Tsobanis E, Kang YK, Bang YJ, Alcindor T, O’Callaghan CJ, Burnell MJ, Tebbutt NC, Rha SY, Lee J, Cho JY, Lipton LR, Strickland A, Zalcberg JR, Simes J, Goldstein D, Pavlakis N. Evaluation of circulating VEGF based biomarkers in INTEGRATE: a randomized phase II double-blind placebo-controlled study of regorafenib in refractory advanced oesophagogastric cancer—a study by the Australasian Gastrointestinal Trials Group (AGITG). Gastrointestinal Cancers Symposium; 21–23 Jan 2016; San Francisco.
  2. Pavlakis N, Sjoquist K, Tsobanis E, Martin A, Kang Y, Bang Y, O’Callaghan C, Tebbutt N, Rha S, Lee J, Cho J, Lipton L, Burnell M, Alcindor T, Strickland A, Wong M, Kim J, Simes J, Zalcberg J, Goldstein D. INTEGRATE: A randomized phase II double-blind placebo-controlled study of regorafenib in refractory advanced oesophagogastric cancer—a study by the Australasian Gastrointestinal Trials Group (AGITG): first results. Gastrointestinal Cancers Symposium; 15–17 Jan 2015; San Francisco.
  3. Pavlakis N, Sjoquist KM, Tsobanis E, Martin AJ, Kang YK, Bang YJ, O’Callaghan CJ, tebbutt NC, Rha SY, Cho JY, Lipton LR, Burnell MJ, Alcindor T, Strickland A, Kim JW, Yip S, SImes J, Zalcberg J, Goldstein D. INTEGRATE: a randomized, phase II, double-blind, placebo-controlled study of regorafenib in refractory advanced oesophagogastric cancer: a study by the Australasian Gastrointestinal Trials Group (AGITG)—final overall and subgroup results. American Society of Clinical Oncology Annual Meeting; 29 May−2 Jun 2015; Chicago.
  4. Pavlakis N, Sjoquist KM, Tsobanis E, Martin AJ, Kang Y-K, Bang Y-J, O’Callaghan CJ, Tebbutt NC, Rha SY, Lee J, Cho JY, Lipton LR, Burnell MJ, Alcindor T, Strickland A, Kim JW, Yip S, Simes J, Zalcberg JR, Goldstein D. INTEGRATE: a randomized phase II double-blind placebo-controlled study of regorafenib in refractory advanced oesophagogastric cancer—a study by the Australasian Gastrointestinal Trials Group: final overall and subgroup results. ESMO 17th World Congress on Gastrointestinal Cancer; 1–4 Jul 2015; Barcelona.
  5. Pavlakis M, Goldstein D, Sjoquist K, Martin A, Tsobanis E, Yip S, Shannon J, Burge M, Cronk M, Tebbutt N, Strickland A, Lipton L, Price T, Nott L, Harris D, Burnell M, Alcindor T, Bang Y, Kang Y, O’Callaghan C. INTEGRATE: A randomized phase II double-blind placebo-controlled study of regorafenib in refractory advanced esophagogastric cancer—a study by the Australasian Gastrointestinal Trials Group (AGITG). American Society of Clinical Oncology Annual Meeting; 31 May–4 Jun 2013; Chicago. Journal of Clinical Oncology; 31(suppl.): TPS4157.

Aim

The purpose of the INTEGRATE study is to investigate if a new drug, regorafenib, is a safe and active treatment for people with stomach cancer who have progressed after treatment with standard chemotherapy.

Principal Investigator

A/Prof Nick Pavlakis