Abemaciclib for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called abemaciclib to determine its effects on recurrent brain tumors. Researchers aim to discover if abemaciclib can halt or slow the growth of tumors, including gliomas and meningiomas. Individuals with recurrent brain tumors after standard treatments and specific tumor types may qualify. Participants must adhere to a treatment plan and undergo imaging tests to monitor progress. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that no other investigational or standard anti-tumor therapy is allowed. Additionally, patients must not be on enzyme-inducing antiepileptic drugs (EIAEDs) and must abstain from grapefruit juice.
Is there any evidence suggesting that abemaciclib is likely to be safe for humans?
Research has shown that abemaciclib has been tested for safety in various cancers, including brain tumors. In earlier studies, many patients tolerated the drug well, with common side effects including tiredness, diarrhea, and low white blood cell counts. Serious side effects were less common.
Another study on abemaciclib for brain conditions found that researchers could safely measure the drug in brain tumors. This allowed them to track how much of the drug reached the brain without causing major issues.
Since this trial is in the middle stage (Phase 2), it indicates that abemaciclib has demonstrated a reasonable level of safety in earlier research. However, individual reactions can vary. Always consult a doctor when considering joining a trial.12345Why do researchers think this study treatment might be promising for brain cancer?
Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, Abemaciclib offers a unique approach by targeting specific proteins called cyclin-dependent kinases (CDK4 and CDK6). These proteins play a critical role in cell division, and by inhibiting them, Abemaciclib can potentially slow down or stop the growth of cancer cells. Researchers are excited about Abemaciclib because it allows for a more targeted intervention, which could lead to better outcomes and fewer side effects compared to traditional chemotherapy. Additionally, its ability to cross the blood-brain barrier makes it a promising option for treating brain tumors, something that many existing drugs struggle to achieve.
What evidence suggests that abemaciclib might be an effective treatment for brain cancer?
Research suggests that abemaciclib may help treat certain brain tumors. This trial will explore its effectiveness across various treatment arms. Studies have shown that abemaciclib can enter the brain, which is crucial for treating brain cancer. In some research, abemaciclib was tested with other drugs and showed promise in killing cancer cells. Additionally, past studies indicated that abemaciclib might be effective when other treatments have failed, especially in hard-to-treat brain cancers like glioblastoma. Overall, while more information is needed, early findings suggest abemaciclib could be effective for some recurring brain tumors.2367
Who Is on the Research Team?
Thomas Kaley, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with recurrent brain tumors, specifically IDH wildtype and RB intact gliomas or other primary brain tumors. Participants must have had prior therapy, be able to swallow pills, consent to use birth control, and not be on certain medications or have specific health conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib for recurrent brain tumors, with some patients undergoing pre-surgical treatment
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?
Memorial Sloan Kettering Cancer Center
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