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Cabozantinib for Patients With Recurrent or Progressive Meningioma

StatusRecruiting
PhasePhase 2
Started2022-06-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-12
Study Status, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v10
Primary completion pushed: 2026-10 → 2026-12
Eligibility criteria+34 characters
[...] quate hematologic function: Absolute Neutrophil Count ≥ 1.5 x× 10^9 / L without granulocyte colony-stimulating factor support. Platelet Count ≥ 100 x× 10^9 / L without transfusion. Hemoglobin ≥ 9 g/dL without t [...] rior to screening assessment. Adequate renal function: ≥ 30 mlmL/min according to the Cockcroft-Gault formula. Adequate hepatic function including: Total bilirubin ≤ 1.5 x× upper limit of normal (ULN). Aspartate transaminase (AST) ≤ 3 x× ULN without liver metastasis. Alanine transaminase (ALT) ≤ 3 x× ULN without liver metastasis. AST or ALT ≤ 5 x× ULN for patients with liver metastasis. [...] [...]
Secondary endpoints4 to 5 entries
ProportionPercent of participants with adverse events (AEs) Percent of participants with Grade 3-5 AEs
2026-03-04
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 3 sites
2026-02-13
Study Status, Contacts/Locations v8
Primary completion date2025-11→2026-10
Study sitescontacts updated at 1 of 3 sites
2025-05-19
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 3 sites
2025-03-05
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 3 sites
Show 5 earlier versions
2024-12-12
Study Status, Contacts/Locations v5
Study sites1→3
2024-06-24
Study Status, Contacts/Locations v4
Start date2022-05-27→2022-06-01
Study sitescontacts updated at 1 of 1 site
2024-05-03
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2023-10-05
Study Status, Contacts/Locations v2
Study sites1 entry, revised
Miami Cancer Institute at Baptist Health, Inc.
2023-05-01
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v1
Primary completion date2023-04-28→2025-11
Completion date2024-04-28→2028-05
Eligibility criteria-122 characters
Inclusion Criteria: Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed. All patients must have [...] se or progressive disease after receiving standard therapy (ege.g., radiation or surgery) > 6 months ago or have been deemed i [...] o receive these therapies. Karnofsky Performance Status ≥ 50 (Appendix 1). Adequate Hematologichematologic Functionfunction: (1) Absolute Neutrophil Count ≥ 1.5 x 10^9 / L without granulocyte colony-stimulating factor support. (2) Platelet Count ≥ 100 x 10^9 / L without transfusion. (3) Hemoglobi [...] [...]
Secondary endpointsdetails revised at 1 of 4 entries
2022-06-17
Original filing
A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma
Trial Details
NCT Number NCT05425004
Lead Sponsor Baptist Health South Florida
Collaborators: Exelixis
Conditions Meningioma
Enrollment 24 participants
Start Date 2022-06-01
Primary Completion 2026-12 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-14