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
230 weeks
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
To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors
CONDITIONS
Official 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 if cognitively impaired)
- Surgical cohort: 18 years or older; Non-surgical cohort: 12 years or older
- Pediatric patients must have body surface area (BSA) of at least 0.9 m2
- Diagnosed with MAPK-activated gliomas, mixed glioma, or glioneural tumors with certain mutations
- Confirmed diagnosis by prior biopsy or resection; prior radiation or chemotherapy required for low-grade and oligodendroglioma patients; prior radiation required for high-grade glioma patients
- Progressive disease per RANO criteria and presence of resectable tumor for surgical cohort
- Progressive disease per RANO criteria for non-surgical cohort
- At least 12 weeks from radiation therapy with evidence of disease progression
- Any number of prior relapses allowed
- Willing to provide archival tissue sample with required slides or tissue block
- Performance status of 60 or higher on Karnofsky Performance Scale
- If on steroids, stable or decreasing dose for one week prior to screening MRI; maximum 16 mg dexamethasone or equivalent daily
- Adequate organ function as defined by laboratory values within 14 days prior to treatment
- Negative pregnancy test for females of childbearing potential within 14 days prior to enrollment
- Agree to use effective contraception during study and for 90 days after last treatment for males and females of childbearing potential
You will not qualify if you...
- Treatment with bevacizumab less than 3 months before enrollment
- Presence of implanted chemotherapy (except if previously resected)
- Less than 12 weeks since completing radiotherapy unless disease progression confirmed
- Participation in another investigational drug or device study for therapy
- Severe immunodeficiency or systemic immunosuppressive therapy (except steroids) within 7 days prior to study entry
- Prior chemotherapy or targeted therapy within 3 weeks prior to study start or unresolved adverse events from previous treatment
- Known additional progressing malignancy requiring active treatment (exceptions apply)
- Active infection requiring systemic therapy
- Conditions or abnormalities that could interfere with study results or participation
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant, breastfeeding, or planning to conceive or father children during the study
- Contraindications for MRI
- Not eligible for non-emergent surgical tumor removal
- Taking prohibited medications that cannot be stopped before 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
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
CONTACT
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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