Regorafenib for the Treatment of Advanced Gastric Cancer (INTEGRATE): A Multinational Placebo-Controlled Phase II Trial.

ABSTRACT:

Purpose

We evaluated the activity of regorafenib, an oral multikinase inhibitor, in advanced gastric adenocarcinoma.

Patients and methods

We conducted an international (Australia and New Zealand, South Korea, and Canada) randomized phase II trial in which patients were randomly assigned at a two-to-one ratio and stratified by lines of prior chemotherapy for advanced disease (one v two) and region. Eligible patients received best supportive care plus regorafenib 160 mg or matching placebo orally on days 1 to 21 of each 28-day cycle until disease progression or prohibitive adverse events occurred. The primary end point was progression-free survival (PFS). Final analysis included data to December 31, 2014.

Results

A total of 152 patients were randomly assigned from Novem

SUBMITTER: Pavlakis N 

PROVIDER: S-EPMC5019744 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature