NCT05804227

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary Objective: 1. Surgical: To evaluate the ability of ulixertinib to penetrate the BBB in patients with recurrent MAPK-activated gliomas (ulixertinib tumor concentration, tumor/plasma ratio) 2. Non-surgical: To assess anti-tumor activity of ulixertinib for patients with recurrent MAPK-activated gliomas (objective response rate (ORR)) Secondary Objectives: 1. To assess anti-tumor activity of ulixertinib for patients with recurrent MAPK-activated gliomas 1. Progression-free-survival (PFS) 2. Overall survival (OS) 3. Disease control rate (DCR) 4. Duration of response (DOR) 5. Time to response (TTR) 6. Time to next intervention 2. To assess safety and tolerability of ulixertinib in MAPK-activated gliomas 3. To evaluate the ability of ulixertinib to reach cerebrospinal fluid (ulixertinib CSF concentration, tumor/CSF ratio)

Conditions

• Gliomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-20
• Primary completion: 2027-09-22
• Completion: 2027-09-22
• First posted: 2023-04-07
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study