• INTEGRATE
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Trial Status

Completed

Cancer Type

Oesophageal Cancer

Protocol Title

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

Purpose of the Study

The purpose of the INTEGRATE study was 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.

The INTEGRATE trial is helping answer an important health question. It has provided evidence that a new treatment, regorafenib, acts against the tumour and is safe. We are now confident that it can be used in a larger trial investigating survival.

Principal Investigator

A/Prof Nick Pavlakis

DETAILED INFORMATION AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR), please click here

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