P-311 - A prospective, observational trial to assess the safety and efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Michel Ducreux
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors M. Ducreux1, A. Cervantes2, A. Falcone3, C.J.A. Punt4, A. Majdi5, J.M. O'Connor6
  • 1Gustave Roussy Cancer Campus Grand Paris, Villejuif/FR
  • 2University Hospital of Valencia, Valencia/ES
  • 3University of Pisa, Pisa/IT
  • 4University of Amsterdam, Amsterdam/NL
  • 5Bayer Consumer Care AG, Basel/CH
  • 6Institute Alexander Fleming, Buenos Aires/AR

Abstract

Introduction

Two randomized, double-blind, phase 3 trials have shown that the oral multikinase inhibitor regorafenib significantly improves overall survival vs placebo in patients with mCRC that has progressed on available treatments (Grothey, et al. Lancet 2013;381:303–312; Kim, et al. Ann Oncol 2014;25[suppl 4]:iv209). The aim of CORRELATE is to characterize the safety and efficacy of regorafenib in the treatment of mCRC in real-world clinical practice.

Trial Design

This prospective, observational, multicenter trial (ClinicalTrials.gov identifier NCT02042144) will be conducted in routine clinical practice settings in more than 25 countries in Europe, Latin America, and the Asia-Pacific region. The trial will recruit approximately 3,000 patients with mCRC previously treated with other approved therapies and for whom the decision to treat with regorafenib has been made.

Patients will receive oral regorafenib 160 mg once daily for weeks 1–3 of each 4-week cycle. Dose interruptions and reductions will be permitted for the management of adverse events.

The primary endpoint is the incidence of treatment-emergent adverse events. Secondary endpoints are overall survival, progression-free survival, disease control rate, health-related quality of life (assessed using the EQ-5D questionnaire), and healthcare resource use. Data sources will include medical records, routine measurements, and patient-reported outcomes.

All patients receiving at least 1 dose of regorafenib will be included in the overall analysis. Two planned interim assessments will occur after 1,000 and 2,000 patients have been observed for at least 3 months. The final analysis will be performed when all patients have been followed for ≥18 months from the time they discontinue regorafenib (unless they withdrew from the trial early because of death, consent withdrawal, or patient/investigator decision to stop). Recruitment is ongoing, with 69 patients enrolled as of March 2015. The estimated primary completion date is September 2017.