NCT00989469

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

October 2, 2009

Last Update Submit

February 3, 2026

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • disease control

    6 months

Secondary Outcomes (3)

  • Assessment of adverse events by using the NCI-CTCAE version 3 scale

    6 months

  • progression free survival

    24 months

  • overall survival

    36 months

Study Arms (1)

Sorafenib and irinotecan

EXPERIMENTAL
Drug: Nexavar (Sorafenib) and irinotecan (Campto)

Interventions

Nexavar (Sorafenib) and irinotecan (Campto)DRUG

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

Sorafenib and irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • Gilbert's disease
  • Brain metastases or carcinomatous symptomatic meningitis
  • Exclusive bone metastasis
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Oscar Lambret

Lille, France

Location

Hopital Saint Eloi

Montpellier, France

Location

Centre Rene Gauducheau

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

CHU Robert Debre

Reims, France

Location

Related Publications (1)

  • Samalin E, Bouche O, Thezenas S, Francois E, Adenis A, Bennouna J, Taieb J, Desseigne F, Seitz JF, Conroy T, Galais MP, Assenat E, Crapez E, Poujol S, Bibeau F, Boissiere F, Laurent-Puig P, Ychou M, Mazard T. Sorafenib and irinotecan (NEXIRI) as second- or later-line treatment for patients with metastatic colorectal cancer and KRAS-mutated tumours: a multicentre Phase I/II trial. Br J Cancer. 2014 Mar 4;110(5):1148-54. doi: 10.1038/bjc.2013.813. Epub 2014 Jan 9.

    PMID: 24407191RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

SorafenibIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloids

Study Officials

  • Emmannuelle SAMALIN-SCALZI, Dr

    CRLC Val d'Aurelle-Paul Lamarque

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2012

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

FR(5)