NCT03969706

Abemaciclib in Patients with Oligodendroglioma

A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients with Recurrent Oligodendroglioma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Stephen Bagley, MD, MSCE · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma

Detailed description

Primary Objective: • To determine the efficacy of abemaciclib for recurrent oligodendroglioma, as measured by the estimated proportion of patients alive without disease progression at 6 months from study enrollment (PFS-6) Secondary Objectives: * To evaluate the safety and tolerability of abemaciclib in recurrent oligodendroglioma * To estimate the objective radiographic response rate (ORR) associated with abemaciclib in recurrent oligodendroglioma * To determine the median progression-free survival (PFS) and overall survival (OS) of patients with recurrent oligodendroglioma treated with abemaciclib * To determine ORR, PFS, and OS in the subgroup of recurrent oligodendroglioma patients with tumor CIC gene mutations Exploratory Objectives: * To measure pharmacodynamic markers of abemaciclib activity on oligodendroglial tumor cells * To identify pre-treatment tumor characteristics that are associated with response to abemaciclib recurrent oligodendroglioma

Conditions

• Oligodendroglioma, Adult

Interventions

Type	Name	Description
DRUG	Abemaciclib 200 MG	Subjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle

Timeline

• Start date: 2019-05-15
• Primary completion: 2025-05-15
• Completion: 2027-05-15
• First posted: 2019-05-31
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study