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Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

NCT05413304 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-03-24

No results posted yet for this study

Summary

Background:

Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults. Most people with these tumors survive less than 2 years. Researchers want to see if an anticancer drug (abemaciclib) can help.

Objective:

To see if researchers can measure how much abemaciclib is in a person's brain tumor and brain fluid after they take the drug for a few days.

Eligibility:

People aged 18 to 39 with recurrent high-grade glioma or diffuse midline glioma.

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Tests of heart function

Imaging scans of the brain, with a contrast agent

Screening tests will be repeated during the study. Participants will also have chest X-rays.

Participants will take abemaciclib by mouth twice a day for 4 and a half days.

Participants will undergo surgery. They will have either a tumor biopsy (a needle will be inserted to remove a small piece of tissue) or a surgical resection (part or all of the tumor will be removed). A small tube (catheter) will be placed in their brain for 48 hours to collect fluid samples. They will have a neurological exam every few hours while the tube is in place. Two days later, the tube will be removed without surgery. Participants will stay in the hospital for about 4 days for treatment.

Based on the results of abemaciclib levels in the brain, participants may keep taking abemaciclib and another drug (temozolomide) by mouth until their cancer gets worse or they have bad side effects. While taking these two drugs, participants will come back to the clinic for follow-up routinely. They will be followed by the study for life....

Conditions

Interventions

DRUG

pre-operative abemaciclib

pre-operatively for 4.5 days; 200mg twice daily (9 total doses)

DEVICE

Device for Cerebral Fluid Dialysate Collection

post-resection or post-biopsy continuous intracerebral microdialysis sampling for 48-hours to assess CNS drug entry and targeted inhibition with abemaciclib

DEVICE

Ashion Analytics GEM ExTra

resection/biopsy genomic sampling of tumor tissue and blood to identify therapeutic targets

DRUG

abemaciclib + temozolomide

abemaciclib 150mg po BID and temozolomide 200mg/m2 po daily x 5 days in 28 day cycles (temozolomide 150mg/m2 po daily x 5 days for cycle 1)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Sadhana Jackson, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2025-10-21
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05413304 on ClinicalTrials.gov