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
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
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