Cabozantinib for Patients With Recurrent or Progressive Meningioma

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT05425004
Phase
PHASE2
Status
Recruiting

Conditions

  • Meningioma

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Cabozantinib tablets are supplied as film coated tablets containing cabozantinib malate equivalent to 20 mg and 60 mg of cabozantinib and contain microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry® yellow. The 60 mg tablets are oval and the 20 mg tablets are round. Doses of 40 mg will comprise two 20-mg tablets. The starting dose for all participants is 60 mg per day by mouth. The study doctor may reduce a participant's dose to 40 mg per day, 20 mg per day, or 20 mg every other day depending on severity of side effects. The study doctor may also increase the dose back up to 60 mg per day if side effects improve.

Study Details

A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma

Key Dates

Start date
Jun 1, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Participants will self-administer cabozantinib 60 mg at the same time daily by mouth on a continuous 28-day schedule. Participants will continue to take this medication as long as they are deriving benefit from it without significant treatment-related toxicities.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Rupesh Kotecha, M.D.
786-596-2000
Anais Vega
(786) 596-2000
Rupesh R Kotecha, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York100653
Thomas Kaley, M.D.
212-639-5122
Vanderbilt University Medical CenterNashvilleTennessee37232
Alexander Mohler, M.D.
615-936-8422

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