Study Comparing Different Dose Approaches of Induction Treatment of Regorafenib in MCRC

Summary

The purpose of this study is to assess the safety and tolerability of different dose-escalation approaches of regorafenib in mCRC patients.

Timeline

Start

2016-07

Primary completion

2018-09

Completion

2019-09

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary end-point was the percentage of patients with G3/G4 treatment-related adverse events (AEs) in each arm. PMID 36335783 ↗

paper G3/4 treatment-related AEs occurred in 60%, 55%, and 54% of patients in arms A, B, and C, respectively. PMID 36335783 ↗

Publications

• Argiles G, Mulet N, Valladares-Ayerbes M, Vieitez JM, Gravalos C, Garcia-Alfonso P, Santos C, Tobena M, Garcia-Paredes B, Benavides M, Cano MT, Loupakis F, Rodriguez-Garrote M, Rivera F, Goldberg RM, Cremolini C, Bennouna J, Ciardiello F, Tabernero JM, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD) and UNICANCER GI; The, REARRANGE investigators; Principal investigator; Argiles G, Tabernero J; Steering Committee; Investigators. A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial). Eur J Cancer. 2022 Dec;177:154-163. doi: 10.1016/j.ejca.2022.09.037. Epub 2022 Oct 14.
• Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.

Drugs

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

Indications