Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

PHASE1RecruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

April 7, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

August 31, 2026

Conditions
Glioma
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)

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH