Oligodendroglioma, Adult Clinical Trial
Official title:
A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients With Recurrent Oligodendroglioma
This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma
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 ;
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