Actively Recruiting
Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
BioMed Valley Discoveries, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the ability of the drug ulixertinib to cross the blood-brain barrier in patients with recurrent MAPK-activated gliomas, a type of brain tumor. The study aims to evaluate how well ulixertinib penetrates the tumor and cerebrospinal fluid, and to assess its anti-tumor activity, safety, and tolerability. This early-phase trial is sponsored by M.D. Anderson Cancer Center and involves patients with specific genetic mutations in their gliomas. Participants are divided into two groups: surgical and non-surgical. Adults in the surgical group will take ulixertinib by mouth twice daily for two weeks before undergoing tumor removal surgery around day 14. The non-surgical group, which includes patients aged 12 and older, will take ulixertinib orally twice daily continuously in 28-day treatment cycles. Pediatric dosing is adjusted based on body surface area. During the study, participants will undergo evaluations including tumor and plasma drug concentration measurements, imaging to assess disease progression, and monitoring for side effects using established criteria. Researchers will also track progression-free survival, overall survival, response duration, and time to next treatment. The study includes safety assessments throughout and plans to monitor patients for an average of one year after starting treatment.
CONDITIONS
Brief Title
Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent or assent, with legally authorized representative consent if cognitively impaired
- Surgical group: 18 years or older; Non-surgical group: 12 years or older
- Pediatric patients must have body surface area of at least 0.9 m2 for accurate dosing
- Diagnosis of MAPK-activated gliomas or related tumors confirmed by pathology or genetic testing
- Prior tumor resection or biopsy confirming glioma diagnosis
- Low grade gliomas must have prior radiation or chemotherapy; high grade gliomas must have prior radiation
- Progressive disease per imaging criteria and presence of resectable tumor for surgical group
- At least 12 weeks from radiation with evidence of disease progression
- Any number of prior relapses
- Willing to provide archival tissue samples
- Performance status of 60 or higher on the Karnofsky Performance Scale
- Stable or decreasing steroid dose, not exceeding 16mg dexamethasone or equivalent daily
- Adequate organ function per specified laboratory values
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during the study and for 90 days after last treatment
You will not qualify if you...
- Treatment with bevacizumab within 3 months prior to enrollment
- Presence of implanted chemotherapy (unless previously resected)
- Less than 12 weeks since completing radiotherapy without biopsy-proven progression
- Participation in another investigational study or use of investigational devices
- Severe immunodeficiency or recent systemic immunosuppressive therapy (except steroids)
- Recent chemotherapy or targeted therapy within 3 weeks before study start without recovery
- Additional active malignancies requiring treatment, except certain skin or cervical cancers
- Active infections needing systemic therapy
- Conditions or abnormalities interfering with trial participation or results
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnancy, breastfeeding, or planning to conceive during the study
- Contraindications for MRI procedures
- Not eligible for non-emergent surgical resection
- Use of prohibited medications unable to be discontinued prior to enrollment
- History or risk of retinal vein occlusion or central serous retinopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical: 2 weeks; Non-Surgical: cycles of 28 days ongoing
Participants in the surgical cohort take Ulixertinib by mouth twice daily for two weeks before undergoing tumor resection. Participants in the non-surgical cohort take Ulixertinib by mouth twice daily continuously in 28-day cycles.
Surgical: 1 baseline visit and 1 surgery visit; Non-Surgical: visits every 28 days per cycle
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nazanin Majd, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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