INTEGRATE IIa

Protocol Title

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

Publication Reference

None to date

Conference Presentation Reference

Sjoquist KM, Pavlakis N, Martin AJ, Tsobanis E, Yip S, Bang YJ, Alcindor T, O’Callaghan CJ, Shitara K, Bekaii-Saab TS, Grothey A, Chen LT, Simes J, Zalcberg R, Goldstein D. Integrate II: A randomised phase 3 double-blind placebo-controlled study of regorafenib in refractory advanced gastro-oesophageal cancer—an international study organized by the Australasian Gastrointestinal Trials Group. American Society of Oncology Annual Meeting; 2–6 Jun 2017; Chicago.

Aim

This study follows the success of the Phase II INTEGRATE study, which demonstrated a positive signal with regorafenib. The purpose of INTEGRATE II is to determine whether Regorafenib improves overall survival as a third line therapy in refractory AGOC. The primary objective is overall survival, while secondary objectives include progression free survival, objective response rates, safety, quality of life, and investigation in patient populations from different geographic regions.

Background

INTEGRATE II is a phase III international multi-centre clinical trial to determine whether Regorafenib is effective in prolonging survival in patients with Advanced Gastro-Oesophageal Carcinoma.

The purpose of this clinical trial is to confirm the activity seen in a previous clinical trial (INTEGRATE), which demonstrated the efficacy of Regorafenib in Advanced Gastro-Oesophageal cancer.

Currently, there are few treatment options for patients with advanced gastro-oesophageal carcinoma that has progressed after first and second line chemotherapy.

Regorafenib is being explored as a possible alternative treatment option. Regorafenib is a multi-targeted therapy that targets a number of signals in the cancer cell that cause it to grow and produce blood vessels. Regorafenib has been proven to have a benefit when other drugs have ceased to work in other cancers, such as colon cancer, liver cancer and gastrointestinal stromal tumours (GIST).

CLINICAL TRIAL DESIGN

INTEGRATE II is a randomised phase III, double-blind, controlled trial with 2:1 randomisation with stratification by the location of tumour, geographic region and prior VEGF inhibitors.

Participants in the trial will be randomly allocated to one of two groups: to receive either Regorafenib or a placebo tablet. The Regorafenib/placebo will be taken once per day for the first 21 days, every four weeks.

Participants will be followed up every 2-4 weeks to evaluate how they are responding to treatment. The effectiveness of the treatment will be evaluated by CT scan every 8 weeks.  Throughout the trial the participant’s medical oncologist will determine whether the participant in suitable for ongoing therapy. Treatment will continue until there is cancer progression or adverse events that prohibit the study from progressing.

There will also be follow up with the patient every 2 months to determine survival.

Participants will not know whether they are taking Regorafenib or the placebo until after the trial is completed. It is planned that the trial will be conducted over two years.

Translational studies will also be conducted to see which patients may benefit the most from this treatment. This will be done by detecting certain biomarkers and drug levels in tumour tissue and blood samples of patients who give consent to participate in these studies.

Patients Recruited

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Study Chairs

Associate Professor Nick Pavlakis (Royal North Shore Hospital, Sydney)
Conjoint Professor David Goldstein (Prince of Wales Hospital, Sydney)

Contact Email

Principal Investigator

Associate Professor Nick Pavlakis

Detailed Information Available on

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

Funding

Bayer HealthCare Pharmaceuticals Inc