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Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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.

NCT00989469•Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

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.
+6 more criteria

Locations (5)

Centre Oscar Lambret

Lille, France

Hopital Saint Eloi

Montpellier, France

Centre Rene Gauducheau

Nantes, France

Centre Antoine Lacassagne

Nice, France

CHU Robert Debre

Reims, France

Key Dates

Start Date

February 1, 2009

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2012

Last Updated

February 5, 2026

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Nexavar (Sorafenib) and irinotecan (Campto)

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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: February 5, 2026Data 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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Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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