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Advanced KRAS Positive Metastatic Colorectal CancerPhase 1NCT02613650

A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers

A Phase 1 study testing MEK162 and mFOLFIRI in people with Advanced KRAS Positive Metastatic Colorectal Cancer, run by University of Utah at 1 site in United States.

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

This is a Phase 1b, open label, dose-finding study to determine the Maximum Tolerated Dose (MTD) of MEK162 in combination with mFOLFIRI, and to evaluate the response rate, clinical benefit rate and additional safety parameters of the treatment combination Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MEK162 and mFOLFIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
19 Aug 2016to 21 Dec 2022
Phase
Phase 1
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

  • Age > 18 years old
  • Patients with histologically confirmed RAS (HRAS, NRAS, or KRAS) positive metastatic colorectal cancer.
  • Patients must have progressed during or after first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy (with failure within six months) or not be a candidate for oxaliplatin (i.e. neuropathy).
  • ECOG Performance Status 0-1
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  • Adequate bone marrow, organ function and laboratory parameters as defined by the protocol
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  • Adequate cardiac function as defined by the protocol
  • Must have recovered from adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE grade 1 peripheral neuropathy is acceptable
  • Willingness and ability to comply with all study procedures and able to take oral medications
  • Dose Expansion Phase Additional Inclusion Criteria
  • Patients must be willing to undergo biopsy according to the institute's own guidelines and requirements for such procedures unless deemed unsafe by the investigator
  • Patients must have measurable disease as defined by RECIST v1.1 (at least one lesion ≥ 10mm in at least one dimension when assessed by CT or MRI, or a cutaneous lesion with clearly defined margins that measures ≥ 10 mm in at least one dimension)
  • Patients must be irinotecan refractory. Patients must have progressed on prior irinotecan therapy but must be able to tolerate standard irinotecan doses.

Who cannot join

  • UGT1A1 *28 homozygous patients
  • Previous treatment with any MEK inhibitor
  • Treatment with systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any investigational therapy ≤ 4 weeks (<6 weeks for nitrosurea or mitomycin-C, antibodies except for trastuzumab) or ≤ 5-half lives of the investigational therapy prior to starting study treatment, whichever is longer
  • Patient received radiotherapy ≤ 2 weeks prior to the first dose of study treatment except localized radiation therapy for symptomatic bone metastasis.
  • Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
  • Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
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  • Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes.
  • Personal history of Gilbert's syndrome.
  • Uncontrolled arterial hypertension defined by blood pressure >150 mmHg systolic and/or 100 mmHg diastolic at rest (average 3 consecutive readings at least 5 minutes apart) despite appropriate medical therapy.
  • Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) <6 months prior to screening,
  • Symptomatic chronic heart failure; evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.
  • Known positive serology for HIV, active Hepatitis B, and/or active Hepatitis C infection (Note: if not suspected, testing is not required at baseline).
  • Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
  • Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment. Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment.
  • Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection that under the judgment of the PI may impair absorption of study drugs).
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication.(patients may not receive drug through a feeding tube), social/ psychological issues, etc.
  • Patients who have undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • A positive β-hCG result will not be exclusionary if it is suspected to originate from a malignancy and the patient has undergone a confirmatory ultrasound within 72 hours prior to starting MEK162 therapy.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from screening through 30 days after the last dose of study drug/treatment discontinuation.
  • Sexually active males, unless they use a condom during intercourse while taking the drug through 90 days after the end of systemic exposure to study drug/treatment. In addition, male participants should not father a child in this period and must refrain from donating sperm during the study through 90 days after the end of systemic exposure of study drug/treatment. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
  • Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: A Phase 1b Trial of a Combination of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers

This is a Phase 1b, open label, dose-finding study to determine the Maximum Tolerated Dose (MTD) of MEK162 in combination with mFOLFIRI, and to evaluate the response rate, clinical benefit rate and additional safety parameters of the treatment combination

Being tested
MEK162 and mFOLFIRI

What participants receive

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

  • MEK162 and mFOLFIRIDrug

    Also called Binimetinib

    MEK162 in combination with mFOLFIRI in a 14 day cycle

    MEK162 will be given single agent 6 day lead in and then will be given in combination with mFOLFIRI

    mFOLFIRI Administered Day 1 of each cycle Irinotecan 180mg/m2 iv over 90 minutes on day 1 5-fluoruracil 1200mg/m2 continuous infusion for 48 hours (2400mg/m2 in 48 hours)

    Followed by MEK162 - Taken twice daily orally on Days 1-12 of each cycle

    Level -1: mFOLFIRI at 80% + MEK162 30 mg twice daily 1 week on and 1 week off Level 1: mFOLFIRI + MEK162 30 mg twice daily Level 2: mFOLFIRI + MEK162 45 mg twice daily

Study groups in NCT02613650
Study groupRoleWhat they receive
MEK162 and mFOLFIRI, all patientsExperimentalNot described
Receives: Drug: MEK162 and mFOLFIRI

What is being measured

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

  1. Incidence of dose limiting toxicities (DLTs) of combination MEK162 and mFOLFIRI

    Measured: Patient safety will be evaluated throughout the treatment period (treatment with MEK162 and mFOLFIRI which is expected to last 6-10 months for each patient)

Secondary outcomes (4)

  1. Response Rate

    Changes in size of target lesions according to RECIST 1.1 to assess PR/CR

    Measured: 2 months

  2. Clinical benefit rate

    Changes in size of target lesions according to RECIST 1.1 to assess PR/CR/SD at 4 months

    Measured: 4 months

  3. Additional Safety

    Incidence of adverse events

    Measured: 9 months

  4. Progression-free survival

    Measured: 9 months

Timeline

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

  1. First posted24 Nov 2015 (estimated)
  2. Study start19 Aug 2016
  3. Primary completion23 Nov 2022
  4. Study completion21 Dec 2022

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613650
Sponsor's protocol ID
HCI87144
Status last verified
May 2026
First submitted
12 Nov 2015
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEK162 and mFOLFIRI in people with Advanced KRAS Positive Metastatic Colorectal Cancer, run by University of Utah at 1 site in United States.

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 13 inclusion and 24 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 12 May 2026. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence of dose limiting toxicities (DLTs) of combination MEK162 and mFOLFIRI (time frame: Patient safety will be evaluated throughout the treatment period (treatment with MEK162 and mFOLFIRI which is expected to last 6-10 months for each patient)). 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 NCT02613650.

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 12 May 2026.

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