← Back to Search

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
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

Study 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.Check my eligibility
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.See study design
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
Select...
My cancer progressed after treatment with anti-EGFR therapy.
Select...
I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My colon or rectum cancer is confirmed and cannot be surgically removed.
Select...
I have recovered from chemotherapy side effects, except for hair loss or mild nerve pain.
Select...
My cancer originated on the left side of my body.
Select...
My tumor does not have mutations in KRAS, NRAS, EGFR, BRAF, or MEK1 genes.
Select...
I am fully active or can carry out light work.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response (complete response [CR] + partial response [PR])
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression-free survival (PFS)

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
~1710
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,170 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,443 Total Patients Enrolled
Christine M ParseghianPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04616183 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Arm B (ERK1/2 inhibitor LY3214996, cetuximab, abemaciclib), Arm A (ERK1/2 inhibitor LY3214996, cetuximab)
Colorectal Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04616183 — Phase 1 & 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04616183 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can sign up for this experiment at most?

"That is correct. Based on the information available on clinicaltrials.gov, this study appears to be actively enrolling patients. The trial was first posted on December 2nd 2020 and has since been updated January 24th of this year. Currently, the study is looking for 46 individuals at a single location."

Answered by AI

What are some of the approved indications for cetuximab?

"Cetuximab is frequently used to treat metastatic squamous cell carcinoma of the head and neck (hnscc). However, it can also be given as treatment for other conditions like squamous cell carcinoma if a diagnosis test approved by the FDA suggests there is a high chance of recurrence."

Answered by AI

Does this experiment represent a new way of testing treatments?

"Cetuximab has a long history, with the first clinical trial being conducted in 2005. Since then, it's been approved for Phase 2 drug trials and there are currently 230 live trials in 51 countries."

Answered by AI

Are we still looking for volunteers for this experiment?

"That is correct. The listing on clinicaltrials.gov affirms that the trial is still ongoing and looking for 46 participants at a single site."

Answered by AI

Could you elaborate on other times Cetuximab has been tested in a clinical setting?

"There are currently 230 clinical trials studying Cetuximab, with 46 of them in Phase 3. Some of these research studies are happening in Dresden and Arizona; however, there are 10638 total locations for these investigations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer
2020. "LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04616183.
All > Colorectal Cancer Houston > Rectal Cancer
~8 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top