Cabozantinib for Patients With Recurrent or Progressive Meningioma

Phase 2

Recruiting

• Conditions: Meningioma
• Interventions: Drug: Cabozantinib

• Registration Number: NCT05425004
• Lead Sponsor: Baptist Health South Florida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-11
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib	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 Measures

Name	Time	Method
Progression free survival (PFS)	6 months	Proportion of participants who from start of treatment to 6-months are free from objective tumor progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years	Overall Survival (OS): duration of time from start of treatment until death from any cause. Patients lost-to follow up will be censored at last valid assessment.
Objective response rate (ORR)	2 years	Proportion of participants with confirmed complete response (CR) or partial response (PR) assessed by Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria, relative to the total population of patients enrolled who initiate therapy.
Proportion of participants with adverse events	2 years	Proportion of participants who develop adverse events assessed by CTCAE v5.0 criteria.
Quality of life (QOL)	2 years	QOL will be measured by Functional Assessment of Cancer Therapy-Brain (FACT-Br) Version 4. The FACT-Br questionnaire is a 23-item survey, participants then rate each item on a Likert scale from 0 "not at all" to 4 "very much", and overall, higher ratings are suggestive of better quality of life.; QOL will be assessed at the baseline, day 1 of every cycle (treatment days, every 4 weeks on 28-day cycle, and every 6 weeks on 42-day cycle).

Trial Locations

Locations (3)

Miami Cancer Institute at Baptist Health, Inc.; 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States