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Colon CancerPhase 2EORTC1616NCT03482362

Vinorelbine in Advanced BRAF-like Colon Cancer

A Phase 2 study testing Vinorelbine Tartrate in people with Colon Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Completed

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

Official record
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Trial summary

Vecchione et al showed that suppression of RANBP2 results in mitotic defects only in BRAF-like colon cancer (CC) cells, which leads to cell death. Mechanistically, RANBP2 silencing reduces microtubule outgrowth from the kinetochores, thereby inducing spindle perturbations, providing an explanation for the observed… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Vinorelbine Tartrate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteNetherlands
Study dates
1 Mar 2018to 17 Mar 2020
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

  • Written informed consent for this clinical trial (+ TR (translational research)) must be given according to ICH/GCP and national/local regulations
  • Written documentation of BRAF-like signature CC, including BRAFm and BRAFwt, as determined by the validated assay of Agendia
  • Written documentation of KRAS and BRAF mutational status.
  • Age > 18 years
  • Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon not in a previously irradiated area, treated with at least one or two lines of standard of care therapy, including BRAF inhibitors, for advanced disease
  • WHO performance status of 0-1
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  • Able and willing to undergo blood sampling for pharmacodynamic (PD) analysis;
  • Able and willing to undergo tumor biopsy prior to, during and upon treatment;
  • Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
  • Minimal acceptable safety laboratory values:
  • ANC > 1.5 x 109 /L
  • Platelet count > 100 x 109 /L
  • Hemoglobin > 6.0 mmol/L
  • Hepatic function as defined by serum bilirubin < 1.5 x ULN, ALAT and ASAT < 2.5 x ULN, or ALAT and ASAT < 5 x ULN in patients with liver metastases
  • Renal function as defined by serum creatinine < 1.5 x ULN
  • creatinine clearance > 50 ml/min (by Cockcroft-Gault formula)
  • Negative urine or serum pregnancy test (serum or urine) for female patients with childbearing potential

Who cannot join

  • Any treatment with investigational drugs, including BRAF inhibitors, within 28 days prior to receiving the first dose of investigational treatment
  • Symptomatic or untreated leptomeningeal disease
  • Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy (for at least 4 weeks) are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening (<21 days before start of treatment) demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids.
  • Impairment of gastrointestinal (GI) function or GI disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, any condition inducing malabsorption, small bowel resection)
  • Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection
  • Known allergy or any other adverse reaction to any of the drugs or to any related compound
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  • Women who are pregnant or breast feeding
  • Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms) 9. Radio-, immuno- or chemotherapy within the last 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed
  • 10. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery 11. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients 12. Patients with a known history of hepatitis B or C 13. Patients with cardiac comorbidities (myocardial infarct within 6 months of study start, NYHA class ≥ III, congestive heart failure or instable angina pectoris), uncontrolled hypertension (systolic blood pressure > 150 mm Hg and/or diastolic pressure > 90 mm Hg) or prolonged QT-interval (> 440 ms for men, > 460 ms for women) 14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study 15. Known hypersensitivity to study drug or excipients

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Antoni van Leeuwenhoek

    Amsterdam, North Holland, 1066 CX

Other trials in Netherlands

About this study

Official title: MoTriColor: A Phase II Study of Vinorelbine in Advanced BRAF-like Colon Cancer

Vecchione et al showed that suppression of RANBP2 results in mitotic defects only in BRAF-like colon cancer (CC) cells, which leads to cell death. Mechanistically, RANBP2 silencing reduces microtubule outgrowth from the kinetochores, thereby inducing spindle perturbations, providing an explanation for the observed mitotic defects. Vinorelbine mimics RANPB2 silencing in BRAF-like and BRAFV600E CC cell lines.

These preclinical data represent a strong rationale to also explore the anti-tumor activity of vinorelbine in patients with advanced BRAF-like (both BRAFm and BRAF wild type) CC. Tumors having this gene signature are referred to as "BRAF-like" and have a similar poor prognosis irrespective of the presence of BRAF(V600E) mutation. Since vinorelbine is standard of care in advanced breast and NSCLC, there is ample experience with the dose and schedule as well as with the safety profile and supportive measures required to prevent side-effects.

Conditions
Colon Cancer
Being tested
Vinorelbine Tartrate
Keywords
vinorelbine
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • Vinorelbine TartrateDrug

    Also called Navelbine, Vinorelbine

    Intravenous administration of vinorelbine on day 1 and day 8 in a dose of 30 mg/m2. One treatment cycle is 21 days.

Study groups in NCT03482362
Study groupRoleWhat they receive
Cohort A; KRASmt, BRAFwt, BRAF-like CCExperimentalPatients with KRAS mutant and BRAF wildtype colon cancer that met the BRAF-like signature according to the validated test of Agendia will be treated with vinorelbine tartrate.
Receives: Drug: Vinorelbine Tartrate
Cohort B; KRASwt, BRAFmt, BRAF-like CCExperimentalPatients with KRAS wildtype and BRAF mutant colon cancer that met the BRAF-like signature according to the validated test of Agendia will be treated with vinorelbine tartrate.
Receives: Drug: Vinorelbine Tartrate

What is being measured

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

  1. Doubling of progression free survival

    This means that by vinorelbine treatment the rate of progression drops to 25%.

    Measured: 15 months

Secondary outcomes (7)

  1. Incidence and severity of adverse events

    Measured: 15 months

  2. Overall response rate

    Measured: 15 months

  3. Duration of response

    Measured: 15 months

  4. Time to response

    Measured: 15 months

  5. Overall survival

    Measured: 15 months

  6. Baseline molecular status (mutation/ expression) in tumor tissue of potential predictive markers of tumor response

    The molecular status will be measured by NGS and IHC in tumor tissue.

    Measured: 15 months

  7. Gene alterations/expression profiles (i.e. baseline, relapse) in tumor tissue upon progression

    The molecular status will be measured by NGS and IHC in tumor tissue.

    Measured: 15 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 Mar 2018
  2. Study start1 Mar 2018
  3. Primary completion17 Mar 2020
  4. Study completion17 Mar 2020

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
Non-randomised
Intervention model
Parallel groups
Model description
This is a two-stage, single-arm, multi-center, open-label, two-cohort, clinical, phase II, proof of principal study.
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482362
Sponsor's protocol ID
M16VIB
Acronym
EORTC1616
Status last verified
Aug 2018
First submitted
13 Mar 2018
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine Tartrate in people with Colon Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

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 17 inclusion and 9 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

Doubling of progression free survival (time frame: 15 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 NCT03482362.

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 3 Aug 2025.

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