Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05804227
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Gliomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors

Key Dates

Start date
Apr 20, 2023
Status verified
Feb 2026
Primary completion
Sep 22, 2027
Completion
Sep 22, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surgical
  • Experimental: Non-Surgical

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Nazanin Majd, MD
[email protected]
713-792-4515
Nazanin Majd, MD (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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