Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas

NCT05804227 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-27

No results posted yet for this study

Summary

To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors

Conditions

Interventions

DRUG

Ulixertinib

Surgical: Only adults with recurrent MAPK-activated gliomas will be accrued to the surgical cohort. Patients will receive Ulixertinib by mouth twice a day for two weeks and will undergo tumor resection subsequently on day 14 (+/- 3 working days).

DRUG

Ulixertinib

Non-Surgical: Patients (12 years and above) with MAPK-activated gliomas will receive Ulixertinib by mouth twice a day continuously on a daily basis for cycles of 28 day.

Sponsors & Collaborators

  • BioMed Valley Discoveries, Inc

    collaborator INDUSTRY
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nazanin Majd, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2027-09-22
Completion
2027-09-22
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 NCT05804227 on ClinicalTrials.gov