LY3214996 + Cetuximab / Abemaciclib for Colorectal Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires a washout period (time without taking certain medications) of at least 21 days after the last chemotherapy dose and 14 days after the last radiotherapy session before starting the trial. Additionally, you cannot take medications that strongly affect the enzyme CYP3A4. Other current medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug combination LY3214996 + Cetuximab / Abemaciclib for colorectal cancer?
Research shows that cetuximab, a component of the treatment, has been effective in improving survival and response rates in patients with metastatic colorectal cancer, especially when combined with chemotherapy. This suggests that cetuximab can be a valuable part of treatment strategies for colorectal cancer.12345
What safety information is available for the treatment LY3214996 + Cetuximab / Abemaciclib for colorectal cancer?
What makes the drug LY3214996 + Cetuximab / Abemaciclib unique for colorectal cancer?
This treatment combines LY3214996, a novel drug, with Cetuximab and Abemaciclib, which are known for targeting specific cancer pathways. Cetuximab is a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR), while Abemaciclib inhibits proteins involved in cell division, potentially offering a new approach for patients who have not responded to other treatments.1011121314
What is the purpose of this trial?
This phase Ib/II trial investigates the side effects and best dose of LY3214996 when given together with cetuximab alone or in combination with abemaciclib and to see how well they work in treating patients with colorectal cancer that cannot be removed by surgery (unresectable) and/or has spread to other places in the body (metastatic). Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. LY3214996 and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LY3214996 and cetuximab alone or in combination with abemaciclib may help treat patients with colorectal cancer.
Research Team
Christine M Parseghian, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ERK1/2 inhibitor LY3214996 and cetuximab, with or without abemaciclib, in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Abemaciclib
- Cetuximab
- LY3214996
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator