Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation (NEXIRI)

February 3, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.

A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Centre Oscar Lambret
      • Montpellier, France
        • Hôpital Saint Eloi
      • Nantes, France
        • Centre René Gauducheau
      • Nice, France
        • Centre Antoine Lacassagne
      • Reims, France
        • CHU Robert Debre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18
  • Written informed consent
  • Histologically proven adenocarcinoma of the colon or rectum asymptomatic primary tumour or surgically removed mCRC patients with previously unresectable metastatic disease
  • Patient with at least one tumoral lesion: measurable in a unidimensional way with a spiral scanner according to RECIST, no previous irradiation in this area
  • Disease progression after irinotecan-based chemotherapy
  • Disease progression after one or more previous lines of chemotherapy received in metastatic situation
  • WHO <= 2
  • Patient having a mutated KRAS on 12 or 13 codons on the primary tumour or a metastasis
  • Adequate liver function : Bilirubin ≤ 1,5 x UNL, ASAT ou ALAT ≤ 2,5 x UNL (or < 5 x UNL for subjects having a hepatic insufficiency in connection with hepatic metastases)
  • Polynuclear neutrophils ≥ 1 500/mm3
  • Haemoglobin > 10g/dl
  • Platelets ≥ 100 000/mm3
  • Amylase and lipase < 1,5 x UNL
  • Serum Creatinin < 1,5 x UNL
  • Adapted contraceptive measures during treatment and continued at least three months after end of the treatment
  • Life expectancy > 3 months
  • Affiliated to or benefiting from health insurance

Exclusion Criteria:

  • Gilbert's disease
  • Brain metastases or carcinomatous symptomatic meningitis
  • Exclusive bone metastasis
  • Previous cancers not considered as cured in the 5 years before inclusion (except for baso-cellular skin carcinoma) Surgery (except diagnostic biopsy) or radiotherapy within 4 weeks before inclusion
  • Disorders of the cardiac rhythm requiring an anti-asynchronous treatment (except beta blockers or digoxine within the framework of a chronic auricular fibrillation), unstable coronaropathy or myocardial infarction < 6 months, congestive cardiac failure > Rank II NYHA (Grade 2), uncontrolled arterial hypertension
  • Previous epilepsy crises requiring long term antiepileptic treatment Previous organ transplant requiring immunosuppressor treatment Severe bacterial or fungus infection (> Grade 2 NCI CTC version 3) Known HIV Infection
  • Long term treatment by known inductors of the CYP 3A4 like Rifampicin, Millepertuis (hypericum perforatum), Phenytoin, Carbamazepin, Phenobarbital, Dexamethasone et Ketonazole
  • Known allergy to one of the therapeutic agents
  • Reasons (psychological, family, social or geographical) that could compromise the participation of the patient in the study
  • Intestinal malabsorption or gastro-intestinal surgery being able to affect Sorafenib absorption. Occlusive or sub-occlusive syndrome.
  • Dysphagic patient or patient not being able to take treatment by orally inflammatory
  • Chronic digestive disease involving chronic diarrhoea (NCI N+Bethesda >= 1.2g)
  • Participation in another clinical trial within 30 days before the start of this study
  • Other concomitant experimental drugs or other concomitant anticancer agents (except Irinotecan and Sorafenib)
  • Medical or psychological state that in the opinion of the investigator will not allow the patient to terminate the study or to understand and sign the informed consent form
  • Pregnancy and breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib and irinotecan
Drug: Nexavar (Sorafenib) and irinotecan (Campto)
Sorafenib administrated continuously orally 400 mg twice daily (a daily total dose of 800 mg). Irinotecan 180 mg/m² will be administered IV for 90 minutes every 2 weeks. The first dose of sorafenib will be administered after the first perfusion of irinotecan 180 mg/m² at the first infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease control
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 36 months
36 months
Assessment of adverse events by using the NCI-CTCAE version 3 scale
Time Frame: 6 months
6 months
progression free survival
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Collaborators

Bayer

Investigators

  • Principal Investigator: Emmannuelle SAMALIN-SCALZI, Dr, CRLC Val d'Aurelle-Paul Lamarque

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimated)

October 5, 2009

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEXIRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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