Regorafenib as Single Agent in Patients With Metastatic Colorectal Cancer (mCRC) With Any RAS or BRAF Mutation Previously Treated With FOLFOXIRI Plus Bevacizumab

Phase 2 Terminated 15 enrolled Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) Bayer · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy of single-agent regorafenib in the second-line treatment in metastatic colorectal cancer with any RAS or BRAF mutation previously treated with FOLFOXIRI plus bevacizumab in terms of progression-free survival at 6 months.

Timeline

Start: 2014-06
Primary completion: 2016-02
Completion: 2016-02

Outcome

Missed primary endpoint

Stopped (Enrollment): “The trial was prematurely closed due to lack of accrual”

paper No patient was progression-free at 6 months. PMID 30120161 ↗

Publications

Garcia-Alfonso P, Benavides M, Falco E, Munoz A, Gomez A, Sastre J, Rivera F, Montagut C, Salgado M, Lopez-Ladron A, Lopez R, Ruiz de Mena I, Duran G, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Single-Agent Regorafenib in Metastatic Colorectal Cancer Patients with Any RAS or BRAF Mutation Previously Treated with FOLFOXIRI plus Bevacizumab (PREVIUM Trial). Oncologist. 2018 Nov;23(11):1271-e128. doi: 10.1634/theoncologist.2018-0316. Epub 2018 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Regorafenib	Small molecule	160 mg	Oral