Study on Abemaciclib for Patients with Recurrent Oligodendroglioma

Sponsor: Stephen Bagley, MD, MSCE

Sponsor score: 0

ClinicalTrials ID:NCT03969706

Provider View

This clinical trial is testing how well the drug abemaciclib works in patients with oligodendroglioma, a type of brain tumor, that has returned after previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug abemaciclib can help control oligodendroglioma that has come back after treatment. Researchers want to find out if patients can live without the disease getting worse for at least six months. They will also check how safe the drug is, how well patients tolerate it, and how it affects the tumor. The study will look at how long patients live without the disease progressing and overall survival rates, especially in those with specific gene mutations in their tumors.

Description

This study aims to determine if abemaciclib is effective for treating recurrent oligodendroglioma, a type of brain tumor. The main goal is to see if patients can live without the disease getting worse for six months after starting the study. Researchers will also evaluate the safety and side effects of abemaciclib, how well it works in shrinking the tumor, and how long patients live without the disease progressing. Additionally, the study will explore how the drug affects tumor cells and identify any tumor characteristics that might predict a better response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with oligodendroglioma, confirmed by specific tests showing a genetic feature called 1p/19q codeletion.
  • The tumor must have returned or worsened after previous radiation and at least one type of chemotherapy.
  • Can have had multiple previous treatments, including surgery, as long as there is still measurable tumor left.
  • Must have recovered from severe side effects of previous treatments.
  • Able to swallow pills.
  • Age 18 or older.
  • Good overall health with a performance status score of 60 or higher.
  • Expected to live more than three months.
  • Adequate blood cell counts and organ function based on specific medical tests.

Exclusion Criteria

  • Previous treatment with a CDK4/6 inhibitor.
  • Taking certain anti-seizure medications.
  • Serious medical conditions that would interfere with the study, such as severe lung disease or digestive disorders.
  • Pregnant or breastfeeding women.
  • Active infections requiring treatment or certain viral infections like HIV or active hepatitis.
  • History of serious heart conditions.
  • Unable to comply with study requirements due to medical, neurological, or psychiatric conditions.
  • Prisoners or those involuntarily incarcerated.
  • Currently receiving other cancer treatments or investigational drugs.

Locations

FACILITYZIPCITYSTATE
University of Pennsylvania19104PhiladelphiaPennsylvania

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