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Metastatic Colorectal CarcinomaPhase 2NCT03981614

Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer

A Phase 2 study testing Binimetinib, Palbociclib and Trifluridine and Tipiracil Hydrochloride in people with Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, run by Academic and Community Cancer Research United at 7 sites in United States.

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

This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Binimetinib, Palbociclib and Trifluridine and Tipiracil Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
7 sitesUnited States
Study dates
29 Oct 2019to 2 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histological confirmation of colorectal cancer that is metastatic and/or unresectable
  • Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)
Show all 36Show fewer
  • Platelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)
  • Hemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)
  • Aspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)
  • Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)
  • Negative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only
  • Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications
  • Able and willing to provide informed written consent and able to comply with protocol requirement
  • Able and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • NOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • Willing to provide blood and tissue samples for mandatory correlative research purposes
  • Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)
  • CROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable
  • CROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory
  • CROSSOVER INCLUSION CRITERIA: Measurable disease
  • CROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1
  • CROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy
  • CROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)
  • CROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)
  • CROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)
  • CROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)
  • CROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)
  • CROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)
  • CROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only
  • CROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications
  • CROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements
  • CROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • NOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • CROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes
  • CROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)

Who cannot join

  • Prior treatment with drug targeting BRAF, MEK, ERK, or CDK family
  • NOTE: For the purpose of this protocol, prior treatment with regorafenib is allowed
  • Prior treatment with trifluridine/tipiracil (TAS-102)
  • 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
  • Women of child-bearing potential
  • NOTE: defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation
Show all 58Show fewer
  • NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation >= 42 days prior to registration/randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential
  • Sexually active males
  • NOTE: unless they agree to use highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation and should not father a child in this period
  • Any symptomatic brain metastasis
  • NOTE: Patients previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for >= 4 weeks prior to registration/randomization, with imaging (e.g., magnetic resonance imaging [MRI] or computed tomography [CT]) demonstrating no current evidence of progressive brain metastases at registration/randomization
  • Prior treatment =< 21 days prior to registration/randomization with any other chemotherapy, small molecule inhibitor (e.g. regorafenib), monoclonal antibody, immunotherapy, or radiotherapy
  • NOTE: All toxicities from prior therapy must be =< grade 1 (or =< grade 2 for peripheral neuropathy or alopecia)
  • Impaired cardiovascular function or clinically significant cardiac 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 registration/randomization
  • Symptomatic chronic heart failure (i.e. grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to registration/randomization except atrial fibrillation and paroxysmal supraventricular tachycardia
  • Left ventricular ejection fraction (LVEF) < 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram =< 28 days prior to registration/randomization
  • Uncontrolled hypertension, defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100mmHg despite current therapy
  • History of thromboembolic or cerebrovascular events =< 12 weeks prior registration/randomization. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or submassive) deep vein thrombosis or pulmonary emboli
  • Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks
  • Note: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled
  • Known history of acute or chronic pancreatitis =< 6 months prior to registration/randomization
  • Known positive serology for HIV (human immunodeficiency virus), active hepatitis B, and/or active hepatitis C infection
  • Patients who have neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK) (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
  • History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) =< 12 months prior to registration/randomization
  • Impaired gastrointestinal (GI) function or disease that may significantly alter the absorption of binimetinib or palbociclib (e.g., ulcerative disease, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption) in the opinion of the investigator
  • History or current evidence of retinal vein occlusion (RVO) or current risk factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
  • Leptomeningeal disease
  • Known hypersensitivity to the components of study drugs or its analogs
  • Known medical, psychiatric, substance abuse, or cognitive disorder that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator
  • Patients who have undergone major surgery =< 21 days prior to registration/randomization or who have not recovered from side effects of such procedures
  • Any other co-morbid, systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Previous or concurrent malignancy =< 3 years prior to registration/randomization with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma of the skin
  • Superficial bladder cancer
  • Prostate intraepithelial neoplasm
  • In situ carcinoma of the cervix
  • Other solid tumors treated curatively without evidence of recurrence for >= 3 years prior to registration/randomization
  • NOTE: If there is a history or prior malignancy, must not be receiving other specific anti-cancer treatment such as anti-estrogen, anti-androgen, or other tyrosine kinase inhibitor therapy
  • CROSSOVER EXCLUSION CRITERIA: Prior treatment with drug targeting BRAF, MEK, ERK, or CDK family
  • NOTE: For the purpose of this protocol, prior treatment with regorafenib is allowed
  • CROSSOVER EXCLUSION CRITERIA: 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
  • CROSSOVER EXCLUSION CRITERIA: Women of child-bearing potential
  • NOTE: Defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation
  • NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation >= 42 days of re-registration. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential
  • CROSSOVER EXCLUSION CRITERIA: Sexually active males
  • NOTE: unless they agree to use highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation and should not father a child in this period
  • CROSSOVER EXCLUSION CRITERIA: Any symptomatic brain metastasis
  • NOTE: Patients previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for >= 4 weeks, with imaging (e.g., MRI or CT) demonstrating no current evidence of progressive brain metastases at re-registration
  • CROSSOVER EXCLUSION CRITERIA: Impaired cardiovascular function or clinically significant cardiac 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 re-registration
  • Symptomatic chronic heart failure (i.e., grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to re-registration except atrial fibrillation and paroxysmal supraventricular tachycardia
  • Left ventricular ejection fraction (LVEF) < 50% as determined by a MUGA scan or echocardiogram
  • CROSSOVER EXCLUSION CRITERIA: Uncontrolled hypertension, defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy
  • CROSSOVER EXCLUSION CRITERIA: History of thromboembolic or cerebrovascular events =< 12 weeks prior re-registration. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli
  • Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks
  • Note: Patients with thromboembolic events relat

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers

This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).

SECONDARY OBJECTIVES:

  1. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.

II. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.

III. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.

CORRELATIVE RESEARCH OBJECTIVES:

  1. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.

II. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.

III. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.

After completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.

Being tested
Binimetinib, Palbociclib, Trifluridine and Tipiracil Hydrochloride
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • BinimetinibDrug

    Also called ARRY-162, ARRY-438162, MEK162, Mektovi

    Given PO

  • PalbociclibDrug

    Also called 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991

    Given PO

  • Trifluridine and Tipiracil HydrochlorideDrug

    Also called Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine

    Given PO

Study groups in NCT03981614
Study groupRoleWhat they receive
Arm A (binimetinib, palbociclib)ExperimentalPatients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Binimetinib; Drug: Palbociclib
Arm B (trifluridine and tipiracil hydrochloride)ExperimentalPatients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.
Receives: Drug: Trifluridine and Tipiracil Hydrochloride

What is being measured

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

  1. Progression Free Survival (PFS)

    Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be documented at each enrolling site with no central review planned. PFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.05. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced.

    Measured: Time from randomization date to either disease progression or death from any cause, whichever occurs first, assessed for up to 16 months

Secondary outcomes (3)

  1. Overall Response Rate

    Assessment of response data will be performed on the basis of definitions of responses according to RECIST version (v)1.1. Objective response is defined as a complete or partial response by RECIST v1.1. This will be reported as the number of patients experiencing an objective response.

    Measured: Up to 16 months

  2. Overall Survival (OS)

    Will use Kaplan-Meier methods to evaluate time to event endpoints, and will report median OS and its 95% confidence interval.

    Measured: Time from first dose of study treatment to death from any cause, assessed for up to 24 months

  3. Number of Participants With Adverse Events

    The number of patients experiencing a grade 3+ adverse event, regardless of attribution, will be reported.

    Measured: Up to 24 months

Timeline

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

  1. First posted11 Jun 2019
  2. Study start29 Oct 2019
  3. Primary completion23 Aug 2021
  4. Study completion2 Jul 2024

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
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981614
Sponsor's protocol ID
ACCRU-GI-1618
Other IDs
NCI-2019-03480, ACCRU-GI-1618, P30CA015083
Status last verified
Jul 2024
First submitted
7 Jun 2019
Last updated
22 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Binimetinib, Palbociclib and Trifluridine and Tipiracil Hydrochloride in people with Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, run by Academic and Community Cancer Research United at 7 sites 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 36 inclusion and 58 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 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?

Yes. Results are posted in the registry (first posted 29 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS) (time frame: Time from randomization date to either disease progression or death from any cause, whichever occurs first, assessed for up to 16 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 NCT03981614.

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 22 Aug 2024.

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