Abemaciclib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the drug Abemaciclib, a cancer treatment, might help treat certain advanced solid tumors. These tumors do not originate in the breast and have either spread or cannot be treated with standard methods. The trial focuses on patients whose cancer cells have specific genetic changes in genes like CCND1, CCND2, CCND3, CDK4, or CDK6. Participants will take the drug daily if their tumor has changes in either CCND1, CCND2, or CCND3, or if their tumor has changes in CDK4 or CDK6. Ideal candidates are those whose cancer has one of these specific genetic changes and who have exhausted other effective treatment options. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot have had chemotherapy, biologic therapy, investigational agents, or major surgery within 4 weeks before starting the study. Also, you cannot be on enzyme-inducing antiepileptic drugs unless you can switch to a different type before starting the trial.
Is there any evidence suggesting that Abemaciclib is likely to be safe for humans?
Research has shown that abemaciclib, the drug under study, maintains a consistent and generally manageable safety record across several studies. Patients often report mild side effects that tend to resolve over time. Additionally, safety results for abemaciclib typically indicate mostly minor unwanted effects, suggesting that patients generally tolerate the drug well. Notably, abemaciclib is already approved for treating certain types of breast cancer, which supports its safety profile.12345
Why do researchers think this study treatment might be promising for cancer?
Researchers are excited about Abemaciclib because it offers a novel approach to treating certain cancers by targeting specific proteins involved in cell division. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, Abemaciclib specifically inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). This targeted action can lead to fewer side effects and potentially more effective treatment for cancers with mutations in CCND1, CCND2, CCND3, CDK4, or CDK6 genes. By honing in on these specific pathways, Abemaciclib has the potential to improve outcomes for patients with these genetic profiles, making it an exciting development in cancer therapy.
What evidence suggests that Abemaciclib might be an effective treatment for cancer?
Research shows that abemaciclib holds promise for treating certain types of breast cancer. Studies have found that it can significantly improve survival rates in patients with hormone receptor-positive (HR+) breast cancer. Specifically, the monarchE trial discovered that combining abemaciclib with endocrine therapy (a treatment that blocks hormones) provides a meaningful survival benefit. In this trial, participants will receive abemaciclib to target cancer-related gene abnormalities such as CCND1, CCND2, CCND3, CDK4, or CDK6. These genes are involved in cell growth and division, and abemaciclib works by blocking these processes, potentially slowing or stopping cancer growth.36789
Who Is on the Research Team?
Geoffrey I. Shapiro
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Adults with advanced solid tumors not originating from breast tissue, who have specific genetic alterations in CCND1/2/3 or CDK4/6 and no standard treatment options left. They must be physically capable of taking oral medication, have stable vital organ functions, and agree to use contraception. Excluded are those with recent treatments, certain metastases, active hepatitis B/C or HIV, pregnant or breastfeeding women.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Abemaciclib orally on a daily basis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
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?
Dana-Farber Cancer Institute
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University