AzTrials
AzTrials

Metastatic Colorectal Cancer Patients With KRAS Mutated TumorsPhase 2NEXIRI2NCT01715441

Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

A Phase 2 study testing Sorafenib and irinotecan combination, Sorafenib monotherapy and Irinotecan monotherapy in people with Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sorafenib and irinotecan combination, Sorafenib monotherapy and Irinotecan monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
9 sitesFrance
Study dates
Sep 2012to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years old
  • Histologically confirmed diagnosis of colorectal cancer
  • Asymptomatic or resected primary tumor
  • Metastatic colorectal cancer patient not eligible for curative surgery
  • At least one target lesion:
  • Unidimensionally measurable on cross-sectional imaging
Show all 19Show fewer
  • In an area not previously irradiated
  • Disease progression after failure of active drugs (5-Fu or 5-Fu prodrugs, irinotecan, oxaliplatin, bevacizumab)
  • Patients with bone metastases are eligible if they have other measurable lesions
  • WHO performance status ≤ 2
  • Confirmation of KRAS mutation in codons 12 or 13 in the primary tumor or metastases
  • Total bilirubin ≤ 1.5 ULN, ALT or AST ≤ 2.5 ULN (or < 5 in case of liver impairment)
  • Haemoglobin ≥ 10 g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 ULN
  • Negative pregnancy test in women of childbearing potential
  • Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment in males and females
  • Life expectancy of at least 3 months
  • Informed consent signed prior any study specific procedures
  • Tumor evaluation should be performed within 3 weeks prior to starting treatment

Who cannot join

  • History of Gilbert's syndrome
  • Symptomatic brain metastases or carcinomatous meningitis
  • Bone-only metastases
  • History or presence of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
  • Prior surgery or radiotherapy within 4 weeks before entering the study
  • Cardiac arrhythmia requiring treatment (except for beta-blockers and digoxin), unstable cardiac disease, myocardial infarction within the previous 6 months, > grade II NYHA heart failure, uncontrolled hypertension
Show all 20Show fewer
  • Kalemia lower than normal serum potassium value
  • From ECG, QTc interval > 470 ms
  • History of acute or chronic pancreatitis
  • History of epileptic seizures requiring long-term anticonvulsant therapy
  • History of organ transplantation with use of immunosuppression therapy
  • Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.4.0)
  • Known HIV infection
  • Long-term use of CYP 3A4 enzyme-inducing agents such as rifampicin, St. John's Wort (hypericum perforatum), phenytoin, carbamazepine, phenobarbital, dexamethasone, and ketoconazole
  • Pregnant or breastfeeding women
  • Bowel malabsorption or extended bowel resection that could affect the absorption of sorafenib, occlusive syndrome, inability to take oral medications
  • Inflammatory bowel disease with chronic diarrhea (NCI-CTCAE v.4.0)
  • Participation in another clinical trial 30 days prior to study entry
  • Concurrent treatment with any other investigational product or anticancer therapy (except for irinotecan or sorafenib)
  • Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up).

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Hôpital AVICENNE

    Bobigny, 93009

  • Centre François Baclesse

    Caen, 14076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital LA TIMONE

    Marseille, 13365

  • CRLC Val d'Aurelle-Paul Lamarque

    Montpellier, 34298

  • C.H.U. de REIMS

    Reims, 51092

  • CHU Charles Nicolle

    Rouen, 76038

  • Institut de Cancérologie de l'Ouest - René Gauducheau

    Saint-Herblain, 44805

Other trials in France

About this study

Official title: A Randomized Phase II Trial Assessing Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors After Failure of All Drugs Known to be Effective

The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.

Being tested
Sorafenib and irinotecan combination, Sorafenib monotherapy, Irinotecan monotherapy
Keywords
Metastatic colorectal cancer patients, KRAS mutation, Sorafenib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib and irinotecan combinationDrug

  • Sorafenib monotherapyDrug

  • Irinotecan monotherapyDrug

Study groups in NCT01715441
Study groupRoleWhat they receive
Irinotecan monotherapyActive comparatorIntravenous infusion irinotecan 180 mg/m2 over 90 minutes (D1=D15) with cross over to irinotecan and sorafenib combination at progression.
Receives: Drug: Irinotecan monotherapy
Sorafenib monotherapyActive comparatorOral sorafenib 400 mg twice daily (total dose 800 mg/day) with cross over to irinotecan and sorafenib combination at progression
Receives: Drug: Sorafenib monotherapy
Sorafenib and irinotecan combinationExperimentalIntravenous infusion irinotecan 120 mg/m2 over 90 minutes (D1=D15) at Cycle 1, 150 mg/m² at C2 if no diarrhea > grade 1 and no other toxicity > grade 2, and 180 mg/m² at C3 in the same conditions * Oral sorafenib 400 mg twice daily (total dose 800 mg/day) from C1. 1 cycle = 15 days and 1 course = 4 weeks.
Receives: Drug: Sorafenib and irinotecan combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-progression rate

    To evaluate the non-progression rate at 2 months according to RECIST criteria (Version 1.1)

    Measured: At 2 months

Secondary outcomes (6)

  1. Disease control rate

    According to RECIST criteria (Version 1.1)

    Measured: At 2 months

  2. Treatment-related toxicity

    According to NCI CTC V4.0

    Measured: At 6 months

  3. Overall survival

    Overall survival is defined as the time from the date of inclusion to the date of death from any cause.

    Measured: At 6 months

  4. Quality of life questionnaire

    Using the EORTC QLQ-C30 questionnaire

    Measured: 6 months

  5. Progression Free Survival

    Progression Free Survival is defined as the time from the date of inclusion to first documentation of objective tumor progression or to death due to progression.

    Measured: At 6 months

  6. Response rate

    According to RECIST criteria (Version 1.1)

    Measured: At 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMar 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715441
Sponsor's protocol ID
NEXIRI2
Other IDs
2012-000644-94
Acronym
NEXIRI2
Status last verified
Feb 2026
First submitted
19 Oct 2012
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Samalin E, Fouchardiere C, Thezenas S, Boige V, Senellart H, Guimbaud R, Taieb J, Francois E, Galais MP, Lievre A, Seitz JF, Metges JP, Bouche O, Boissiere-Michot F, Lopez-Crapez E, Bibeau F, Ho-Pun-Cheung A, Ychou M, Adenis A, Di Fiore F, Mazard T. Sorafenib Plus Irinotecan Combination in Patients With RAS-mutated Metastatic Colorectal Cancer Refractory To Standard Combined Chemotherapies: A Multicenter, Randomized Phase 2 Trial (NEXIRI-2/PRODIGE 27). Clin Colorectal Cancer. 2020 Dec;19(4):301-310.e1. doi: 10.1016/j.clcc.2020.04.008. Epub 2020 May 15.

    PubMed 32737004

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib and irinotecan combination, Sorafenib monotherapy and Irinotecan monotherapy in people with Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-progression rate (time frame: At 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01715441, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in