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Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients | Clinical Trials | Clareo Health

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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

NCT03829462•Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent obtained before any study specific procedures
•Male or female ≥ 18 years of age
•Histological documentation of adenocarcinoma of the colon or rectum
•Patients with metastatic colorectal cancer
•Progression during or within 3 months following the last administration of approved standard therapies, which must include a fluoropyrimidine (or raltitrexed), oxaliplatin, irinotecan, anti Vascular endothelial growth factor (VEGF) therapy and an anti Epithelial Growth Factor Receptor (EGFR) therapy (for RAS wild-type tumors)
•Eastern Cooperative Oncology Group (ECOG) performance status ≤1
•Life expectancy of at least 3 months
•Patients with A/A cycline D1 (CCND1) genotype of rs603965 CCND1
•Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Amylase and lipase ≤1.5 x Upper Limit Normal (ULN),Total bilirubin ≤ 1.5 x ULN,Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer), Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5.0 x ULN for patients with liver involvement for their cancer and/or have bone metastases), Platelet count ≥ 100,000/mm3; Hemoglobin (Hb) ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1,500/ mm3. Transfusion to meet the inclusion criterion, Serum creatinine ≤ 1.5 x ULN
•International normalized ratio (INR) ≤ 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g., heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care
+2 more criteria

Exclusion Criteria

•Patients with A/G or G/G cycline d1 (CCND1) genotype of rs603965 CCND1
•Prior treatment with regorafenib or sorafenib
•Prior treatment with TAS 102
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
•Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug
•Congestive heart failure ≥ New York Heart Association (NYHA) class 2
•Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
•Myocardial infarction less than 6 months before start of study drug
•Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
•Uncontrolled hypertension. (Systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management)
+25 more criteria

Locations (11)

Centre Antoine Lacassagne

Nice, Alpes-Maritimes, France

Centre François Baclesse

Caen, Basse-Normandie, France

Hôpital Pontchaillou

Rennes, Ile Et Vilaine, France

Hôpital Robert Debré

Reims, Marne, France

Institut Godinot

Reims, Marne, France

Hôpital Saint-Jean

Perpignan, Pyrénées-orientales, France

Centre Léon Bérard

Lyon, Rhône, France

Hôpital privé Jean Mermoz

Lyon, Rhône, France

Institut Gustave Roussy

Villejuif, Val De Marne, France

CRLC Val d'Aurelle-Paul Lamarque

Montpellier, France

Key Dates

Start Date

March 28, 2019

Primary Completion Date

September 4, 2024

Completion Date

September 1, 2026

Last Updated

November 21, 2025

Enrollment

377

ACTUAL participants

Conditions

Metastatic Colorectal Cancer (mCRC)

Interventions

Regorafenib

DRUG

Irinotecan

DRUG

Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients

NCT02069704

Metastatic Colorectal Cancer (mCRC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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