613TiP - A prospective, observational trial to further assess safety and efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) in rou...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Michel Ducreux
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors M. Ducreux1, A. Falcone2, C.J.A. Punt3, J. Thaler4, C.H. Poehlein5, A. Cervantes Ruiperez6
  • 1Department Of Gastroenterlogy, Gustave Roussy Cancer Campus Grand Paris, 94805 - Villejuif/FR
  • 2Dept. Of Translational Research And New Technologies In Medicine, University of Pisa, IT-56126 - Pisa/IT
  • 3Medical Oncology, Academic Medical Center, University of Amsterdam, 1100 DD - Amsterdam/NL
  • 4Department Of Internal Medicine Iv, Hematology, Medical Oncology And Palliative Care, Nephrology And Dialysis, Klinikum Wels-Grieskirchen GmbH, A-4600 - Wels/AT
  • 5Oncology, Bayer Healthcare Pharmaceuticals, 07981-0915 - Whippany/US
  • 6Department Of Hematology And Medical Oncology, University Hospital of Valencia, INCLIVA Biomedical Research Institute, 46010 - Valencia/ES

Abstract

Background

The oral multikinase inhibitor regorafenib significantly improved overall survival vs placebo (HR 0.77, p = 0.0052) in patients with mCRC that progressed on available treatments in the randomized, double-blind, placebo-controlled CORRECT trial (Grothey, Van Cutsem et al. Lancet 2013). CORRELATE will characterize the safety and efficacy of regorafenib 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 3,000 patients with mCRC previously treated with other approved therapies and for whom a decision has been made to treat with regorafenib. 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, assessed using National Cancer Institute Common Terminology Criteria for 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 outcome questionnaires. All patients receiving ≥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 ≥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 under way, with the first patient enrolled in April 2014; the estimated primary completion date is July 2017.

Disclosure

M.P. Ducreux: has the following financial disclosures: Advisory board: Merck, Roche, Bohringer, Amgen, Novartis, Sanofi Corporate sponsored research: Roche, Pfizer Employment (wife): Sandoz; A. Falcone: Advisory Boards for Amgen, Bayer, Roche, Merck Serono, Sanofi and Corporate Sponsored Research for Amgen, Bayer, Roche, Merck Serono, Sanofi; C.J.A. Punt: has the following financial disclosures: Advisory board: Roche, Amgen, Sanofi, Nordic Pharma, Bayer; J. Thaler: has the following financial disclosures: Advisory board: Bayer, Merck . All other authors have declared no conflicts of interest.