Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults
- Registration Number
- NCT05804227
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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. To evaluate the ability of ulixertinib to penetrate the BBB in patients with recurrent MAPK-activated LGG (ulixertinib tumor concentration, tumor/plasma ratio and tumor/cerebrospinal fluid (CSF) ratio)
Secondary Objectives:
1. To assess anti-tumor activity of ulixertinib for patients with recurrent lower grade
MAPK-activated gliomas after surgical resection based on:
1. Median progression-free-survival (mPFS)
2. Objective response rate (ORR) at 12 months
3. Disease control rate (DCR) at 12 months
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 LGG
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: CIC-mutated oligodendroglioma Ulixertinib - Cohort 1: NF1-muated low-grade glioma Ulixertinib -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 through study completion; an average of 1 year.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States