Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas
To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors
| Condition(s) | Gliomas |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors |
| Who can participate | Inclusion criteria: 1. Be willing and able to provide written informed consent for the trial (by participant or legally authorized representative), and assent when applicable. Participants with cognitive impairment will be enrolled. Cognitive function will be assessed by the treating physician or designee through a neurological examination. The formal consent for such participants will be obtained from their legally authorized representative. 2. Surgical: Be 18 years of age or older on day of signing informed consent. Non-surgical: Be 12 years of age or older on day of signing informed consent. \*Pediatric patients will be dosed at the RP2D of 260mg/m2 EVERY 12 HRS continuously for 28-day cycles. The pediatric maximal single dose is 450mg. Since the smallest tablet strength of ulixertinib |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2023-04-20 |
| NCT ID | NCT05804227 |
| Official listing | https://clinicaltrials.gov/study/NCT05804227 |