Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
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Clinical Trial Information
Trial Contact: Dubberly, Paige D; Armatti, Julie M; Parker, Melanie; Doyle, Katherine M; Frankos, Marie
Trial Phone: 321-841-7561 ; 321-843-5284 ; 321-843-1036 ; 3218412008 ; 321-842-8738
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IRB No: C23.150.08
Protocol Abbrev: AOST2032
Principal Investigator:
Phase: Drug: Phase II
Age Group: Pediatric
ClinicalTrials.gov ID: NCT05691478
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Objective
PRIMARY OBJECTIVES:
I. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma.
III. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma.
