NCT02981940

A Study of Abemaciclib in Recurrent Glioblastoma

A Phase 0/2 Study of Abemaciclib in Recurrent Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a targeted therapy as a possible treatment for recurrent glioblastoma (GBM). The following intervention will be used in this study: -Abemaciclib

Detailed description

This research study is a Phase 0/II clinical trial. Phase 0 clinical trials use only a few small doses of a drug. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved abemaciclib as a treatment for any disease. Many brain cancers show over expression of a protein called cyclin D1. That means that the body makes too much cyclin D1, which affects enzymes called CDK 4 and CDK 6. Enzymes are substances in the body that help reactions between cells happen. Too much cyclin D1 triggers CDK 4 and CDK 6 to make more cells than normal. This extra cell production leads to the growth of tumors. In laboratory studies, Abemaciclib was able to enter the brain, stop CDK 4 and CDK 6 from making cells, and slow growth of mice Glioblastoma. In this research study, the investigators are looking to see how safe and effect Abemaciclib is with the participant type of cancer. In the surgical participants, the investigators are looking to see if Abemaciclib reached the brain tumor.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Abemaciclib capsule
PROCEDURE	Surgery	Surgery

Timeline

• Start date: 2017-02-09
• Primary completion: 2024-06-30
• Completion: 2026-06-30
• First posted: 2016-12-05
• Last updated: 2025-09-02
• Results posted: 2025-09-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study