A Study of Abemaciclib in Recurrent Glioblastoma
ClinicalTrials.gov Identifier: NCT02981940
UCLA IRB #: 16-001874
Sponsors: Dana-Farber Cancer Institute, Eli Lilly and Company
Time Frame: 2 years
Purpose: This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an Experimental drug to learn whether the drug works in treating a specific disease. “Experimental” means that the drug is still being studied and that research doctors are trying to find out more about it–such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. The purpose of the research study is to see how safe and effect abemaciclib is with your type of cancer. In the surgical participants enrolled into Group 1, we are looking to see if abemaciclib reached the brain tumor.
This study has two treatment Groups:
Group 1: only enroll patients who will be undergoing surgery for their recurrent brain tumor. Participants in Group 1 will receive abemaciclib for 6-11 days prior to their scheduled surgery as well as on the day of the surgery. They will resume the study drug cycle (twice per day, 28 days per cycle) between 14 and 35 days after the date of surgery.
Group 2: patients don’t have to have a planned surgery for their recurrent brain tumor to be enrolled into Group 2. Participants in Group 2 will receive abemaciclib twice per day, 28 days per cycle. The purpose of the research study is to see how safe and effect abemaciclib is with your type of cancer. In the surgical participants enrolled into Group 1, we are looking to see if abemaciclib reached the brain tumor. This consent form will only discuss Group 1 of the study.
Principal Investigator: Timothy Cloughesy, MD