Abemaciclib + Bevacizumab for Recurrent Brain Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain treatments are prohibited, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Abemaciclib and Bevacizumab for recurrent brain cancer?
Bevacizumab has shown promising results in treating recurrent glioblastoma, a type of brain cancer, by targeting and neutralizing VEGF, a protein that helps tumors grow blood vessels. Studies have reported improved survival rates in patients with recurrent glioblastoma when treated with Bevacizumab.12345
Is the combination of Abemaciclib and Bevacizumab safe for treating recurrent brain cancer?
Bevacizumab, also known as Avastin, has been used for treating recurrent high-grade gliomas (a type of brain cancer) and is generally considered safe, though it may not improve overall survival. It has been approved in several countries for this purpose, indicating a recognized safety profile in humans.24567
How is the drug combination of Abemaciclib and Bevacizumab unique for treating recurrent brain cancer?
The combination of Abemaciclib and Bevacizumab is unique because it targets both cell division and blood vessel growth in tumors. Abemaciclib inhibits proteins that help cancer cells divide, while Bevacizumab blocks a protein called VEGF that tumors use to grow new blood vessels, potentially improving treatment effectiveness for recurrent brain cancer.12458
What is the purpose of this trial?
Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations
Eligibility Criteria
This trial is for adults over 18 with recurrent glioblastoma brain tumors, who have specific genetic changes in their tumor. They must be able to take oral meds, have good organ function, and a performance status of at least 60%. Women of childbearing age and men with partners must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-In
Participants receive Abemaciclib 150 mg orally twice daily with Bevacizumab 10 mg/kg intravenously every 2 weeks for 2 cycles to assess safety and adverse events
Treatment
Participants continue treatment with Abemaciclib and Bevacizumab for additional cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Bevacizumab
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?
University of Texas Southwestern Medical Center
Lead Sponsor
Edward Pan
Lead Sponsor