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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Ulixertinib
Drug
Surgical: Only adults with recurrent MAPK-activated gliomas will be accrued to the surgical cohort. Patients will receive Ulixertinib by mouth twice a day for two weeks and will undergo tumor resection subsequently on day 14 (+/- 3 working days).
Ulixertinib
Drug
Non-Surgical: Patients (12 years and above) with MAPK-activated gliomas will receive Ulixertinib by mouth twice a day continuously on a daily basis for cycles of 28 day.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: SurgicalExperimental treatment 1 intervention

Group B: Non-SurgicalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

BioMed Valley Discoveries, Inc

Collaborator

Source ClinicalTrials.gov

Apply now