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CDK4/6 Inhibitor

LY3214996 + Cetuximab / Abemaciclib for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Led By Christine M Parseghian

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior treatment with, and progression on, anti-EGFR therapy (cetuximab or panitumumab)

Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization

Must not have

Known leptomeningeal disease

Active infection requiring concurrent antibiotic use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment until death or disease progression as defined by recist version 1.1 criteria for the evaluable population, assessed up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating the side effects and best dosage of LY3214996 when given with cetuximab to treat patients with unresectable and/or metastatic colorectal cancer. Cetuximab is an antibody that may interfere with the ability of tumor cells to grow and spread, while LY3214996 and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with colorectal cancer that's spread and can't be removed by surgery. They must have tried at least one chemotherapy, recovered from its effects, and not have certain gene mutations. Participants need to be in good physical condition (ECOG <=1), able to take oral meds, and women must avoid pregnancy.

What is being tested?

The study tests LY3214996 with cetuximab alone or combined with abemaciclib on unresectable/metastatic colorectal cancer. It aims to find the best dose of LY3214996, see how well these treatments work together, and understand their side effects.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to monoclonal antibodies like cetuximab, as well as issues affecting cell growth which could result from blocking enzymes with LY3214996 or abemaciclib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer progressed after treatment with anti-EGFR therapy.

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I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.

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My kidney function, measured by creatinine levels, is within the normal range.

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My colon or rectum cancer is confirmed and cannot be surgically removed.

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I have recovered from chemotherapy side effects, except for hair loss or mild nerve pain.

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My cancer originated on the left side of my body.

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My tumor does not have mutations in KRAS, NRAS, EGFR, BRAF, or MEK1 genes.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to the lining of my brain and spinal cord.

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I am currently taking antibiotics for an infection.

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I have brain metastases that are causing symptoms.

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I have a history of serious heart rhythm problems or sudden cardiac arrest.

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I haven't had major surgery in the last 6 weeks or still have side effects.

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My high blood pressure is not controlled, even with medication.

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My cancer has specific genetic mutations.

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My colon cancer is on the right side or in the middle.

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I am taking medication that strongly affects liver enzyme CYP3A4.

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My heart health is good and I don't have major heart diseases.

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My stomach or intestines do not work well, affecting how I absorb medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment until death or disease progression as defined by recist version 1.1 criteria for the evaluable population, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment until death or disease progression as defined by recist version 1.1 criteria for the evaluable population, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until death or disease progression as defined by recist version 1.1 criteria for the evaluable population, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best overall response (complete response [CR] + partial response [PR])

Secondary study objectives

Incidence of adverse events

Overall survival

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (ERK1/2 inhibitor LY3214996, cetuximab, abemaciclib)Experimental Treatment3 Interventions

Patients receive ERK1/2 inhibitor LY3214996 and cetuximab as in Arm A. Patients also receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (ERK1/2 inhibitor LY3214996, cetuximab)Experimental Treatment2 Interventions

Patients receive ERK1/2 inhibitor LY3214996 PO QD on days 1-28 and cetuximab IV over 1-2 hours on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Cetuximab

2011

Completed Phase 3

~2480