NCT03829462

Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients

A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and Lonsurf) no longer have treatment options available while maintaining a good performance status which would allow them to receive a new treatment

Detailed description

A Phase II randomized trial compared Nexiri (Nexavar® + Irinotecan) vs irinotecan or versus Sorafenib (Nexavar®). The patients treated with Irinotecan or Sorafenib alone could receive NEXIRI combination after progression (crossover to Nexiri). Regorafenib, which is an oral signal deactivation agent with a chemical structure very similar to Sorafenib, is a standard treatment in heavily pretreated mCRC patients since the results of CORRECT study which compared Regorafenib to placebo on overall survival. Sorafenib isn't approved in mCRC so the objective of this NEXT-REGIRI trial is compared REGIRI combination (Regorafenib-Irinotecan) to Regorafenib alone in a phase III trial in patients in progression after having received all standard treatments and bearing genotype A/A of cyclin D1. The study's hypothesis is that regorafenib could have effects similar to those of sorafenib.

Conditions

• Metastatic Colorectal Cancer (mCRC)

Interventions

Type	Name	Description
DRUG	Regorafenib	regorafenib tab 40 mg i.e 160 mg/day
DRUG	Irinotecan	irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more

Timeline

• Start date: 2019-03-28
• Primary completion: 2024-09-04
• Completion: 2026-09-01
• First posted: 2019-02-04
• Last updated: 2025-11-21
• Results posted: 2025-07-18

Locations

11 sites across 1 country: France