Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas
ConditionGliomas
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors
Eligibility criteria
Qualifiers
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.
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.
MAPK-activated gliomas, mixed glioma or glioneural tumors, including but not limited to those with mutations in BRAF, FGFR, PTPN11, somatic NF-1, NF-1 syndrome-associated gliomas, and recurrent oligodendrogliomas, CIC mutated. Somatic-only NF-1-mutated grade 3, 4 astroctyoma will not be included.
Mutational status requires a pathology report, genomic sequencing, or immunohistochemical report of a mutation or activation of the RAS/RAF/MEK/ERK pathway.
Disqualifiers
Treatment with bevacizumab less than 3 months prior to enrollment.
Presence of implanted chemotherapy. Previously resected implanted chemotherapy is not excluded.
Less than 12 weeks from completing radiotherapy. Patients with proven progressive disease by biopsy or partial resection or with new lesions outside of the radiation field should not be excluded even if they are within 12 weeks of radiation.
Patient currently participating in a study of an investigational agent or using an investigational device for therapeutic purposes.
Trial design
Treatments tested in this trial
- Ulixertinib
- Ulixertinib
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
BioMed Valley Discoveries, Inc
Collaborator
Source ClinicalTrials.gov